Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Davol, Inc. — Predicate Candidate Screening

50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time

233 days90th percentile

50clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251557	Bard® Mesh; Bard® Mesh Pre-Shaped	Davol, Inc.	2025-06-12	22	0
K250098	Bard Soft Mesh; Bard Soft Mesh Pre-Shaped	Davol, Inc.	2025-04-09	85	0
K031213	AQUASENS FLUID MONITORING SYSTEM	Davol, Inc.	2003-04-30	13	0
K030307	DAVOL ARTHROVENT OUTFLOW TUBING	Davol, Inc.	2003-02-13	15	0
K003323	COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0	Davol, Inc.	2001-01-22	90	3
K003790	DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 555100	Davol, Inc.	2000-12-22	14	0
K931899	DAVOL ATS	Davol, Inc.	1994-11-15	575	0
K941334	DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE	Davol, Inc.	1994-06-14	88	0
K921405	DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP	Davol, Inc.	1994-03-25	731	0
K935503	DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET	Davol, Inc.	1994-03-07	111	0
K926479	BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM	Davol, Inc.	1994-03-01	427	0
K931552	DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT	Davol, Inc.	1993-10-08	193	0
K932327	THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM	Davol, Inc.	1993-07-13	61	0
K930147	SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY	Davol, Inc.	1993-06-22	161	0
K924144	ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)	Davol, Inc.	1993-04-08	233	0
K924592	DAVOL KNOT PUSHER	Davol, Inc.	1992-12-17	98	0
K914119	DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM	Davol, Inc.	1992-12-03	447	0
K921755	8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS	Davol, Inc.	1992-10-23	193	0
K922526	DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES	Davol, Inc.	1992-09-02	97	0
K920659	DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES	Davol, Inc.	1992-06-05	114	0
K914755	DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT	Davol, Inc.	1992-03-30	160	0
K915536	DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC	Davol, Inc.	1992-03-26	107	0
K915406	DAVOL ELECTROSUGICAL PROBES	Davol, Inc.	1992-02-28	88	0
K914910	DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)	Davol, Inc.	1992-01-06	66	8
K914526	DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)	Davol, Inc.	1991-11-22	44	0
K913684	DAVOL POST-OP AUTOTRANSFUSION SYSTEM	Davol, Inc.	1991-11-15	88	0
K913235	DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH	Davol, Inc.	1991-10-31	101	0
K913028	ARTHRO-FLOW IRRIGATION 2 SYSTEM	Davol, Inc.	1991-10-10	93	0
K912702	PLASTIC ATTACHABLE DUAL PORT	Davol, Inc.	1991-09-18	91	0
K911205	ARTHROSCOPY INSTRUMENT CANNULA	Davol, Inc.	1991-06-17	90	0
K910486	8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER	Davol, Inc.	1991-04-19	72	0
K905448	THORA-KLEX CHEST DRAINAGE UNIT	Davol, Inc.	1991-03-27	112	0
K910340	LAPAROSCOPIC ASPIRATION PROBE	Davol, Inc.	1991-02-26	29	0
K904558	DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL	Davol, Inc.	1991-02-11	129	0
K905016	PEDIATRIC AND INFANT CATH KITS	Davol, Inc.	1990-12-20	43	0
K902722	BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM	Davol, Inc.	1990-11-16	149	0
K901401	DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM	Davol, Inc.	1990-10-23	211	0
K903530	PERCUTANEOUS INTRODUCERS	Davol, Inc.	1990-10-22	77	0
K896127	THORA-KLEX CHEST DRAINAGE UNIT	Davol, Inc.	1990-01-24	93	0
K894990	DAVOL ARTHROSCOPY CANNULA	Davol, Inc.	1989-11-08	92	0
K800081	DAVOL/ABAMSON SILICONE SUMP DRAIN	Davol, Inc.	1980-01-28	14	0
K792332	DAVOL/SIMON DERMATOME	Davol, Inc.	1979-12-06	17	0
K792281	USHER'S MARLEX TUBULAR MESH	Davol, Inc.	1979-11-27	14	1
K791306	ELLIK EVACUATOR	Davol, Inc.	1979-08-03	18	0
K791137	SINGLE USE MONOPOLAR HAND CONTROL PENCIL	Davol, Inc.	1979-07-24	36	12
K782027	HYSTERECTOMY T DRAIN	Davol, Inc.	1978-12-20	15	0
K782028	ROUND SILICONE DRAIN	Davol, Inc.	1978-12-20	15	0
K782026	FLAT SILICONE DRAIN	Davol, Inc.	1978-12-12	7	0
K780724	BUBBLE SUCTION TUBING	Davol, Inc.	1978-06-02	30	0
K772292	T-TUBE WHELAN-MOSS	Davol, Inc.	1977-12-20	8	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