Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Davol Inc., Sub. C. R. Bard, Inc. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
298 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101851 | VENTRALIGHT ST MESH | Davol Inc., Sub. C. R. Bard, Inc. | 2010-07-15 | 14 | 2 |
| K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 01 | Davol Inc., Sub. C. R. Bard, Inc. | 2009-12-08 | 155 | 1 |
| K081010 | BARD 3DMAX MESH | Davol Inc., Sub. C. R. Bard, Inc. | 2008-10-07 | 181 | 0 |
| K061754 | BARD COMPOSITE L/P MESH | Davol Inc., Sub. C. R. Bard, Inc. | 2006-10-23 | 124 | 0 |
| K061314 | BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH | Davol Inc., Sub. C. R. Bard, Inc. | 2006-06-02 | 22 | 0 |
| K051848 | SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 011307 | Davol Inc., Sub. C. R. Bard, Inc. | 2005-08-11 | 35 | 0 |
| K050610 | SALUTE FIXATION SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 2005-05-25 | 76 | 8 |
| K011069 | AQUASENS FLUID MONITORING SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 2001-08-16 | 129 | 0 |
| K003674 | NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK T | Davol Inc., Sub. C. R. Bard, Inc. | 2000-12-08 | 9 | 0 |
| K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO | Davol Inc., Sub. C. R. Bard, Inc. | 1999-09-13 | 110 | 0 |
| K991637 | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 | Davol Inc., Sub. C. R. Bard, Inc. | 1999-06-22 | 41 | 0 |
| K982867 | HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 00253 | Davol Inc., Sub. C. R. Bard, Inc. | 1999-02-19 | 189 | 0 |
| K970078 | HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 1997-12-11 | 336 | 0 |
| K971745 | BARD COMPOSITE PROSTHESIS | Davol Inc., Sub. C. R. Bard, Inc. | 1997-08-06 | 86 | 0 |
| K964879 | PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 | Davol Inc., Sub. C. R. Bard, Inc. | 1997-03-04 | 89 | 0 |
| K964211 | DAVOL PLUME FILTER (5541420) | Davol Inc., Sub. C. R. Bard, Inc. | 1996-12-02 | 41 | 0 |
| K961224 | HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 1996-05-16 | 48 | 0 |
| K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 | Davol Inc., Sub. C. R. Bard, Inc. | 1996-05-15 | 27 | 0 |
| K953577 | BARD VISILEX MESH 3 X 6 | Davol Inc., Sub. C. R. Bard, Inc. | 1995-09-26 | 57 | 0 |
| K951026 | DAVOL ARTHRO-FLO 3 | Davol Inc., Sub. C. R. Bard, Inc. | 1995-06-02 | 88 | 0 |
| K933384 | BARD HYSTERO-FLO II PUMP | Davol Inc., Sub. C. R. Bard, Inc. | 1994-12-30 | 536 | 0 |
| K935617 | ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION | Davol Inc., Sub. C. R. Bard, Inc. | 1994-09-16 | 298 | 0 |
| K942886 | SIMPULSE SOLO SUCTION IRRIGATOR | Davol Inc., Sub. C. R. Bard, Inc. | 1994-07-19 | 32 | 0 |
| K936102 | DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCO | Davol Inc., Sub. C. R. Bard, Inc. | 1994-05-17 | 146 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda