Davol Inc., Sub. C. R. Bard, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Davol Inc., Sub. C. R. Bard, Inc.” (first 1994, latest 2010), plus 1 PMA decision, across 9 product codes in 4 review panels. Median 510(k) review time under this name: 87 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 8 | 8 |
| HIG | Insufflator, Hysteroscopic | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| HRX | Arthroscope | 3 | 3 |
| GDW | Staple, Implantable | 2 | 2 |
| FQH | Lavage, Jet | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | 1 | 0 |
Review panels
Most recent Davol Inc., Sub. C. R. Bard, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101851 | VENTRALIGHT ST MESH | FTL | 2010-07-15 | 14 |
| K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 | FTL | 2009-12-08 | 155 |
| K081010 | BARD 3DMAX MESH | FTL | 2008-10-07 | 181 |
| K061754 | BARD COMPOSITE L/P MESH | FTL | 2006-10-23 | 124 |
| K061314 | BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH | FTL | 2006-06-02 | 22 |
| K051848 | SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 | GDW | 2005-08-11 | 35 |
| K050610 | SALUTE FIXATION SYSTEM | GDW | 2005-05-25 | 76 |
| K011069 | AQUASENS FLUID MONITORING SYSTEM | HIG | 2001-08-16 | 129 |
| K003674 | NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP | GEI | 2000-12-08 | 9 |
| K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO | HIG | 1999-09-13 | 110 |
14 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N17600 | PMA | AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) | 1976-08-26 |
Recalls
32 product recalls in 13 recall events; 0 initiated in the last five years. Most recent: 2011-10-04.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Davol, Inc. (50 510(k)s)
- Davol Inc., Subsidiary of C. R. Bard, Inc. (4 510(k)s)
- Davol, Inc., A Subsidiary of C.R. Bard, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Davol Inc., Sub. C. R. Bard, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Davol Inc., Sub. C. R. Bard, Inc.” (first 1994, latest 2010), plus 1 PMA decision, across 9 product codes in 4 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 Davol Inc., Sub. C. R. Bard, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Davol Inc., Sub. C. R. Bard, Inc. is 87 days.
Which FDA product codes appear under Davol Inc., Sub. C. R. Bard, Inc.?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 8); HIG (Insufflator, Hysteroscopic, 5); GCJ (Laparoscope, General & Plastic Surgery, 3).
Next steps
- See all 24 Davol Inc., Sub. C. R. Bard, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTL, Davol Inc., Sub. 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.