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

GAD · Predicate Candidate Screening

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

36 daysmedian FDA review time

182 days90th percentile

100clearances measured

K-number	Device	Applicant	Decided	Review days
K152538	JRP Wound Spreader	J.R. Parker, LLC	2016-04-13	222
K151104	OTELO LL	Spineart	2016-01-06	257
K132645	THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES	Medtronic, Inc.	2013-10-04	42
K071775	DASH	Ezsurgical	2007-08-07	39
K050256	APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR	Apple Medical Corp.	2005-04-26	82
K043602	QUADRANT RETRACTOR SYSTEM	Medtronic Sofamor Danek	2005-02-23	56
K001339	MRI FASTSYSTEM RETRACTOR SYSTEM	Omni-Tract Surgical, Div. Minn. Scientific, Inc.	2000-05-17	20
K980588	CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000	Clarus Medical Systems, Inc.	1998-08-18	182
K963006	SCION SAPHENOUS VEIN HARVESTING SYSTEM	Scion International, Inc.	1996-09-20	49
K943875	VILLALTA RETRACTOR	Hct, Inc.	1994-11-09	93
K942002	RETRACTOR	Automated Medical Products Corp.	1994-05-17	22
K941448	RETRACTOR	Technovations	1994-04-15	22
K930316	LUNG RETRACTORS: DAVIDSON, SEMB	Thomasville Medical Assoc.	1994-02-10	384
K926585	THOROCOSCOPY SELF-RETAINING RETRACTOR	T. Korossurgical Instruments Corp.	1993-08-06	322
K921020	HARGIS SELF RETRACTION SYSTEM	Medin Corp.	1993-07-02	486
K921017	HARGIS SR2 SELF-RETRACTION SYSTEM	Medin Corp.	1993-07-02	486
K921019	HARGIS RECTAL SELF RETRATION SYSTEM	Medin Corp.	1993-07-02	486
K922626	ADEPT INSTRUMENT POSITIONING ACCESSORY	Andronic Devices, Ltd.	1992-10-19	138
K922625	ADEPT ENDOSCOPIC POSITIONER	Andronic Devices, Ltd.	1992-10-19	138
K920471	LEVY ARTICULATING RETRACTOR	Lifeguard Medical Products, Inc.	1992-06-23	147
K914190	AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR	United States Surgical, A Division of Tyco Healthc	1992-05-06	231
K915175	REDDICK RETRACTOR	Ideal Medical, Inc.	1992-04-29	166
K915158	SUREBREATH DOME, E-Z BREATHER	Ipax, Inc.	1992-02-12	90
K910975	TEKDYNE MICRO RETRACTOR	Tekdyne	1991-04-01	25
K903969	SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET	Karlin Technology, Inc.	1990-09-05	8
K893869	GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)	Adept-Med Intl., Inc.	1989-08-03	69
K893871	GOOTT BALFOUR BLADE	Adept-Med Intl., Inc.	1989-08-03	69
K893121	ROBOTRAC (TM) RETRACTOR ARM	Aesculap Instruments Corp.	1989-06-01	37
K891892	ROLLET RETRACTOR	Zinnanti Surgical Instruments, Inc.	1989-04-12	19
K891031	KIRSCHNER RETRACTOR	Zinnanti Surgical Instruments, Inc.	1989-04-06	37
K890820	LOCKING WIRE GUIDE STYLET	Medical Engineering and Development Institute	1989-03-22	33
K890250	SURGICAL WIRE CUTTERS	Kinetic Medical Products	1989-01-27	9
K890248	SURGICAL RETRACTORS	Kinetic Medical Products	1989-01-27	9
K890247	SURGICAL RETRACTORS	Kinetic Medical Products	1989-01-27	9
K884076	SUREBREATH DOME	Ipax, Inc.	1988-10-07	10
K882074	SUCTION RETRACTORS	Karlin Technology, Inc.	1988-06-16	30
K882075	SELF-RETAINING SOFT TISSUE RETRACTOR	Karlin Technology, Inc.	1988-06-16	30
K882112	MURSE RETRACTOR	Euro-American Marketing Group, Inc.	1988-06-15	27
K881157	STERNUM SPREADER AND MITRAL VALVE RETRACTOR	T. Korossurgical Instruments Corp.	1988-04-06	19
K881159	I.M.A. RETRACTOR	T. Korossurgical Instruments Corp.	1988-04-05	18
K881156	UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR	T. Korossurgical Instruments Corp.	1988-04-05	18
K880998	STERNUM SPREADER, PEDIATRIC	T. Korossurgical Instruments Corp.	1988-03-21	13
K880997	SPRING RETRACTOR	T. Korossurgical Instruments Corp.	1988-03-21	13
K880813	SELF-RETAINING SOFT TISSUE RETRACTOR	T. Korossurgical Instruments Corp.	1988-03-11	14
K880151	HIP, FEMUR AND HUMERUS RETRACTOR	Twenty-First Century Orthopedics, Inc.	1988-02-18	36
K875289	SUCTION RETRACTOR	T. Korossurgical Instruments Corp.	1988-01-22	23
K874243	ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000	Pilling Co.	1987-11-13	28
K872919	OMNI-TRACT CORRAL RETRACTOR	Minnesota Scientific, Inc.	1987-08-11	15
K870543	STERI-TRACTOR WOUND RETRACTOR	3M Company	1987-02-24	15
K864424	RAYLOR(TM) PROTECTIVE RETRACTOR	Cedar Surgical, Inc.	1986-11-26	16

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