C.R. Bard, Inc.: FDA filings under this applicant name
FDA lists 655 510(k) clearances under the applicant name “C.R. Bard, Inc.” (first 1976, latest 2026), plus 5 PMA decisions, across 190 product codes in 11 review panels. Median 510(k) review time under this name: 78 days. Since 2017 the median was 124 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under BD (Becton, Dickinson and Company), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 12 | 86 |
| 2013 | 11 | 71 |
| 2014 | 14 | 59 |
| 2015 | 19 | 162 |
| 2016 | 20 | 95 |
| 2017 | 15 | 103 |
| 2018 | 7 | 140 |
| 2019 | 7 | 128 |
| 2020 | 5 | 109 |
| 2021 | 6 | 160 |
| 2022 | 4 | 184 |
| 2023 | 2 | 76 |
| 2024 | 0 | — |
| 2025 | 2 | 148 |
| 2026 | 4 | 214 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name C.R. Bard, Inc. took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 34 | 34 |
| FTL | Mesh, Surgical, Polymeric | 26 | 26 |
| FRN | Pump, Infusion | 22 | 22 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 22 | 22 |
| DQO | Catheter, Intravascular, Diagnostic | 16 | 16 |
| DYB | Introducer, Catheter | 16 | 16 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 16 | 16 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 15 | 15 |
| DQY | Catheter, Percutaneous | 14 | 14 |
| DTK | Filter, Intravascular, Cardiovascular | 13 | 13 |
Plus 180 more product codes.
Review panels
- Cardiovascular (195)
- Gastroenterology and Urology (191)
- General Hospital (124)
- General and Plastic Surgery (88)
- Anesthesiology (23)
- Radiology (15)
- Obstetrics and Gynecology (14)
- Orthopedic (5)
- Ear, Nose and Throat (1)
- Physical Medicine (1)
- Clinical Toxicology (1)
Most recent C.R. Bard, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | KNT | 2026-07-10 | 246 |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | FCM | 2026-05-29 | 162 |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | GEX | 2026-03-17 | 181 |
| K251864 | Rubber Utility Catheter | KOD | 2026-02-23 | 251 |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | LDF | 2025-05-15 | 29 |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | LDF | 2025-01-31 | 266 |
| K230356 | Aspirex Thrombectomy System | QEW | 2023-03-31 | 50 |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | LIT | 2023-01-20 | 101 |
| K222793 | WavelinQ Generator | GEI | 2022-10-17 | 31 |
| K220270 | Aspirex Thrombectomy System | QEW | 2022-06-21 | 141 |
645 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170042 | PMA | Covera Vascular Covered Stent | 2018-07-30 |
| P030030 | PMA | URYX URETHRAL BULKING AGENT | 2004-12-16 |
| P920027 | PMA | ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II | 1994-10-21 |
| P860064 | PMA | DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KIT | 1988-02-29 |
| P800002 | PMA | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB | 1980-10-24 |
Recalls
173 product recalls in 52 recall events; 49 initiated in the last five years. Most recent: 2026-06-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named C.R. Bard, Inc. is the lead sponsor of 85 device studies on ClinicalTrials.gov (8 active or recruiting). Most recent:
- NCT07282860: An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males (Enrolling by invitation, started 2025-11-24)
- NCT07016698: Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry) (Recruiting, started 2025-09-29)
- NCT06850259: This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting. (Completed, started 2025-03-21)
- NCT05945329: Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation (Recruiting, started 2024-12-12)
- NCT06669806: Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension (Recruiting, started 2024-11-21)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under C.R. Bard, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- A4648 — Tissue marker, implantable, any type, each (via NEU)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
- G0379 — Direct admission of patient for hospital observation care (via DWM)
Frequently asked questions
How many FDA 510(k) clearances are listed under C.R. Bard, Inc.?
FDA lists 655 510(k) clearances under the applicant name “C.R. Bard, Inc.” (first 1976, latest 2026), plus 5 PMA decisions, across 190 product codes in 11 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by C.R. Bard, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name C.R. Bard, Inc. is 78 days. Since 2017: 124 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under C.R. Bard, Inc.?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 34); FTL (Mesh, Surgical, Polymeric, 26); FRN (Pump, Infusion, 22).
Next steps
- See all 655 C.R. Bard, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, C.R. Bard, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.