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

Valleylab, Inc. — Predicate Candidate Screening

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

68 daysmedian FDA review time

204 days90th percentile

94clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K031011	LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500	Valleylab, Inc.	2003-05-29	59	2
K010010	VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-	Valleylab, Inc.	2001-04-02	90	0
K010013	LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100	Valleylab, Inc.	2001-03-26	83	2
K994428	E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE	Valleylab, Inc.	2000-03-07	68	0
K983743	BISURE LAPAROSCOPIC BIPOLAR FORCEPS	Valleylab, Inc.	1999-01-21	90	0
K981916	LIGASURE VESSEL SEALING SYSTEM	Valleylab, Inc.	1998-08-28	88	0
K981262	CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM	Valleylab, Inc.	1998-07-06	90	3
K980915	VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM	Valleylab, Inc.	1998-06-29	110	0
K970140	E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH	Valleylab, Inc.	1997-03-28	72	0
K964636	FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM	Valleylab, Inc.	1997-03-11	112	0
K964601	CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRA	Valleylab, Inc.	1997-01-16	59	0
K964602	DAVIS BAYONET ELECTRODES	Valleylab, Inc.	1997-01-09	52	0
K964175	VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES	Valleylab, Inc.	1996-12-05	48	0
K962690	E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 -	Valleylab, Inc.	1996-11-04	116	0
K962044	VALLEYLAB COATED ELECTRODES	Valleylab, Inc.	1996-08-30	94	0
K955836	VALLEYLAB COATED ELECTRODES	Valleylab, Inc.	1996-02-01	37	0
K955109	VL2600 HANDSWITCHING PENCIL WITH HOLSTER	Valleylab, Inc.	1995-12-18	40	0
K954229	ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX	Valleylab, Inc.	1995-11-20	70	0
K953737	VL7600 REM PATIENT RETURN ELECTRODE	Valleylab, Inc.	1995-08-23	13	0
K953195	VALLEYLAB FORCE 300	Valleylab, Inc.	1995-08-21	42	0
K934628	CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS	Valleylab, Inc.	1995-07-11	664	0
K945688	VALLEYLAB PROCISION(TM) SYSTEM	Valleylab, Inc.	1995-06-13	204	0
K946177	VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM	Valleylab, Inc.	1995-06-06	169	0
K944602	VALLEYLAB FORCE FX	Valleylab, Inc.	1995-06-05	259	0
K950945	COOPER LASER SONICS CUSA MODEL 200	Valleylab, Inc.	1995-04-10	82	0
K950188	VALLEYLAB COATED ELECTRODES	Valleylab, Inc.	1995-02-10	24	0
K944244	MODEL E278OR-ASP SERIES RETRACTABLE	Valleylab, Inc.	1994-11-30	90	0
K945260	E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCIL	Valleylab, Inc.	1994-11-09	12	0
K943865	FORCE GSU-SLPM SYSTEM	Valleylab, Inc.	1994-09-23	46	0
K942579	FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22	Valleylab, Inc.	1994-09-21	113	0
K931902	CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.	Valleylab, Inc.	1994-09-16	515	0
K942183	E2550 REUSABLE HANDSWITCHING PENCIL	Valleylab, Inc.	1994-05-17	13	0
K941968	VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC	Valleylab, Inc.	1994-05-10	18	0
K921885	E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES	Valleylab, Inc.	1994-03-25	703	0
K926481	VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET	Valleylab, Inc.	1994-02-12	410	0
K933181	VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500	Valleylab, Inc.	1993-11-02	125	0
K933239	CV720-727-000, MICROTIP AND FLUE PAK	Valleylab, Inc.	1993-10-12	102	0
K925647	VALLEYLAB #E2751 & E2780R LAPAROSCOPIC HANDPIECE	Valleylab, Inc.	1993-09-29	324	0
K922206	SURGISTAT	Valleylab, Inc.	1993-09-07	483	0
K931028	VALLEYLAB RETRACTABLE ELECTRODES	Valleylab, Inc.	1993-07-27	148	0
K926414	VALLEYLAB MACROBIPOLAR FORCEPS HANDPIECE, E3200	Valleylab, Inc.	1993-05-17	145	0
K926415	VALLEYLAB CURRENT MONITOR, E3350 & E3351	Valleylab, Inc.	1993-04-23	121	0
K924524	FORCE GSU(TM) HANDSET W/3 & 6 FLEXIBLE EXTENDER	Valleylab, Inc.	1993-04-05	209	0
K924918	FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM)	Valleylab, Inc.	1993-01-29	122	0
K921884	FORCE 2	Valleylab, Inc.	1992-12-15	238	0
K921222	FORCE 1C	Valleylab, Inc.	1992-09-23	194	0
K922090	FORCE GSU SYSTEM W/ LAPAROSCOPIC OPTION	Valleylab, Inc.	1992-08-04	91	0
K921251	CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR	Valleylab, Inc.	1992-06-12	88	0
K914400	MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS	Valleylab, Inc.	1991-10-17	15	0
K910696	CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR	Valleylab, Inc.	1991-06-11	112	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