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

Cabot Medical Corp. — Predicate Candidate Screening

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

98 daysmedian FDA review time

492 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960148	CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT	Cabot Medical Corp.	1996-03-25	74	0
K946109	CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS	Cabot Medical Corp.	1995-11-21	342	0
K951972	CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERA	Cabot Medical Corp.	1995-07-21	85	0
K951714	CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC L	Cabot Medical Corp.	1995-07-11	88	0
K941743	CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP	Cabot Medical Corp.	1995-04-19	377	0
K934115	3000 ELECTRONIC INSUFFLATOR MODIFICATION	Cabot Medical Corp.	1995-03-15	568	0
K932293	CABOT MEDICAL BIPOLAR CUTTING FORCEPS	Cabot Medical Corp.	1994-07-27	442	3
K930954	THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV	Cabot Medical Corp.	1994-06-30	492	0
K932626	CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB	Cabot Medical Corp.	1994-06-08	372	0
K935786	CORSON AND NEZHAT SUCTION/IRRIGATION PROBES	Cabot Medical Corp.	1994-05-19	164	0
K924631	CABOT MEDICAL UTERINE RESECTOSCOPE	Cabot Medical Corp.	1994-05-16	609	0
K940171	CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM	Cabot Medical Corp.	1994-03-09	57	0
K923570	CRYOMEDICS LLETZ LOOPS	Cabot Medical Corp.	1994-02-28	591	0
K932538	CABOT MEDICAL IRRIGATION FLUID WARMER SETS	Cabot Medical Corp.	1994-02-22	272	0
K932976	CABOT MEDICAL OPTIMA HAND INSTRUMENTS	Cabot Medical Corp.	1993-09-07	82	0
K932977	CABOT MEDICAL OPTIMA HAND INSTRUMENTS	Cabot Medical Corp.	1993-09-07	82	0
K931649	LAPAROSCOPIC BALLOON RETRACTOR	Cabot Medical Corp.	1993-08-06	123	0
K923945	PLEATMAN SAC SPECIMEN CONTAINER	Cabot Medical Corp.	1993-02-05	185	1
K924530	CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI	Cabot Medical Corp.	1993-02-05	150	0
K924048	CABOT DISPOSABLE 10MM SUCTION DEVICE	Cabot Medical Corp.	1993-01-22	164	0
K923210	SYSTEM 3000 XENON VIDEOLAP LIGHT	Cabot Medical Corp.	1992-10-05	96	0
K913873	SYSTEM 3000 ELECTRONIC INSUFFLATOR	Cabot Medical Corp.	1992-03-20	204	0
K895402	ENDOCOAGULATOR 2001 KLI	Cabot Medical Corp.	1990-04-26	231	0
K896917	HYSTEROSCOPE	Cabot Medical Corp.	1990-03-05	84	0
K895907	HYSTEROFLATOR 2001	Cabot Medical Corp.	1989-12-14	69	0
K894186	SURGIFLEX LASER CONTACT TIPS	Cabot Medical Corp.	1989-09-12	88	0
K880763	NEZHAT IRRIGATION PUMP SYSTEM	Cabot Medical Corp.	1988-05-24	89	0
K873527	DECHERNEY HYSTEROSCOPY PUMP SYSTEM	Cabot Medical Corp.	1988-02-26	178	0
K875084	CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE	Cabot Medical Corp.	1988-02-08	61	0
K873115	CABOT FIBER LASER PROBE	Cabot Medical Corp.	1988-01-28	171	0
K871960	ELECTRO-GYNE ELECTROSURGICAL GENERATOR	Cabot Medical Corp.	1987-07-10	51	0
K862228	CABOT LASER LAPAROSCOPY ACCESSORY SET	Cabot Medical Corp.	1986-08-20	70	0
K862310	CABOT MEDICAL VARIABLE FLOW INSUFFLATOR	Cabot Medical Corp.	1986-08-12	56	0
K861859	CABOT VIDEOSCOPE	Cabot Medical Corp.	1986-05-30	16	0
K850298	ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM	Cabot Medical Corp.	1985-03-05	40	0
K840831	ENDOTOME PNEUMATIC ORTHOPAEDIC CUT	Cabot Medical Corp.	1984-04-04	40	0
K834146	ANTHROSCOPY SYSTEM	Cabot Medical Corp.	1984-03-08	98	0
K833727	CABOT ARTHROSCOPY SYSTEM	Cabot Medical Corp.	1983-12-12	28	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