Davol, Inc.: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Davol, Inc.” (first 1977, latest 2025), plus 1 PMA decision, across 25 product codes in 6 review panels. Median 510(k) review time under this name: 89 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 | 2 | 54 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Davol, Inc. took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 6 | 6 |
| CAC | Apparatus, Autotransfusion | 5 | 5 |
| HRX | Arthroscope | 5 | 5 |
| FTL | Mesh, Surgical, Polymeric | 4 | 4 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 4 | 4 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | 2 | 2 |
| KDQ | Bottle, Collection, Vacuum | 2 | 2 |
Plus 15 more product codes.
Review panels
- General and Plastic Surgery (19)
- General Hospital (10)
- Obstetrics and Gynecology (7)
- Cardiovascular (6)
- Orthopedic (5)
- Gastroenterology and Urology (4)
Most recent Davol, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | FTL | 2025-06-12 | 22 |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | FTL | 2025-04-09 | 85 |
| K031213 | AQUASENS FLUID MONITORING SYSTEM | HIG | 2003-04-30 | 13 |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | HRX | 2003-02-13 | 15 |
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | FTL | 2001-01-22 | 90 |
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 | GCJ | 2000-12-22 | 14 |
| K931899 | DAVOL ATS | CAC | 1994-11-15 | 575 |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | HET | 1994-06-14 | 88 |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | HFG | 1994-03-25 | 731 |
| K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET | HIF | 1994-03-07 | 111 |
40 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050038 | PMA | ARISTA AH ABSORBABLE HEMOSTAT | 2006-09-26 |
Recalls
8 product recalls in 4 recall events; 8 initiated in the last five years. Most recent: 2026-03-25.
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.
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., Sub. C. R. Bard, Inc. (24 510(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.?
FDA lists 50 510(k) clearances under the applicant name “Davol, Inc.” (first 1977, latest 2025), plus 1 PMA decision, across 25 product codes in 6 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.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Davol, Inc. is 89 days.
Which FDA product codes appear under Davol, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6); CAC (Apparatus, Autotransfusion, 5); HRX (Arthroscope, 5).
Next steps
- See all 50 Davol, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Davol, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.