Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

1993 — Predicate Candidate Screening

4,167 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

169 daysmedian FDA review time

413 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K931673	CARAPACE CATARACT TRAYS	Carapace, Inc.	1993-12-30	268	0
K934690	KERR OPTIBOND, MODIFICATION	Kerr Corporation (Danbury)	1993-12-30	157	0
K930125	PHOENIX BONE SCREWS PBS-TYPE SERIES	Phoenix Bioengineering, Inc.	1993-12-30	352	0
K934428	ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY	Sherwood Medical Co.	1993-12-30	111	0
K933884	STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASC	Strato Medical Corp.	1993-12-30	142	0
K931873	VACVENT	Steven Frank Mercereau	1993-12-30	260	0
K922730	LAKE OSTOMY CARE SET	Lake Medical Products, Inc.	1993-12-30	573	0
K934062	BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS	Biotrack, Inc.	1993-12-29	132	0
K932548	ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS	Roche Diagnostic Systems, Inc.	1993-12-29	217	0
K934923	CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET	Unipath , Ltd.	1993-12-29	77	0
K933852	PRO-LOK EXTENSION SET	Beech Medical Products, Inc.	1993-12-29	145	0
K935652	NAMTAI	Nam Tai Electronics (Canada) , Ltd.	1993-12-29	36	0
K934061	BIOTRACK VALPROIC ACID TEST CARTRIDGE	Biotrack, Inc.	1993-12-29	132	0
K933625	BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM	Cobe Cardiovascular, Inc.	1993-12-29	163	6
K933732	BEECH PROLOK	Beech Medical, Inc.	1993-12-29	149	0
K934922	CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET	Unipath , Ltd.	1993-12-29	77	0
K933895	PHX TECHNOLOGIES CORP., GRASPER-RETRACTOR DEVICE	Phx Technologies Corp.	1993-12-29	141	0
K933749	BEECH VERSA LOK	Beech Medical Products, Inc.	1993-12-29	148	0
K934168	CEDIA DIGOXIN PLUS ASSAY	Microgenics Corp.	1993-12-29	124	0
K934930	OLYMPIC AUTO-LENGTH	Olympic Medical Corp.	1993-12-29	76	0
K935320	PHENCYCLIDINE EIA ASSAY	Diagnostic Reagents, Inc.	1993-12-29	76	0
K930500	MAXIVIEW DIAGNOSTIC WORKSTATION	Dimensional Medicine, Inc.	1993-12-29	331	0
K932692	INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT	Innerdyne Medical, Inc.	1993-12-27	207	0
K933709	PASCO MIC AND MIC/ID PANELS	Pasco Laboratories, Inc.	1993-12-27	150	0
K934212	FAST SPIN ECHO	Hitachi Medical Systems America, Inc.	1993-12-27	119	0
K933844	PARA 4 PLUS	Streck Laboratories, Inc.	1993-12-27	143	0
K932384	IDEIA(TM) ROTAVIRUS	Dako Diagnostics , Ltd.	1993-12-27	224	0
K930778	IMMUNOCARD MONO	Meridian Diagnostics, Inc.	1993-12-27	314	0
K933724	SENSOR-TIP TROCAR	Origin Medsystems, Inc.	1993-12-27	147	0
K933236	CORDIS OPTA 5(TM), MODIFICATION	Cordis Corp.	1993-12-27	207	0
K934149	MICRO-TECH TRU CANAL	Micro-Ear Technology, Inc.	1993-12-27	125	0
K932954	AVOXIMETER	A-Vox Systems, Inc.	1993-12-27	193	0
K933746	PASCO MIC AND MIC/ID PANELS	Pasco Laboratories, Inc.	1993-12-27	146	0
K933872	VISI-SPEAR EYE SPONGE	Visitec Co.	1993-12-27	143	0
K932101	DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING	Convatec, A Division of E.R. Squibb & Sons	1993-12-27	238	0
K932704	PATIENT CABLE	Sentry Medical Products, Inc.	1993-12-27	207	0
K932422	3M TEGADERM HP TRANSPARENT DRESSING	3M Health Care, Ltd.	1993-12-27	222	0
K926230	EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN	Convatec, A Division of E.R. Squibb & Sons	1993-12-23	377	0
K924176	SABA INTIMA	Scott Paper Co.	1993-12-23	491	0
K934739	DAVINCI CHOLANGIOGRAM DELIVERY DEVICE	Da Vinci Medical, Inc.	1993-12-23	83	0
K920664	DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION	Diagnostic Ultrasound Corp.	1993-12-23	679	0
K935310	MEDICAL LASER MIXTURE	Acetylene Gas Co.	1993-12-23	51	0
K935260	PHYSIOMETRIX CABLE ADAPTER MODIFICATION	Physiometrix, Inc.	1993-12-23	51	0
K924177	CONFORT	Scott Paper , Ltd.	1993-12-23	491	0
K924175	SABA CONFORT	Scott Paper Co.	1993-12-23	491	0
K923568	TROCAR STABILITY THREAD	Applied Medical Resources	1993-12-23	524	0
K933686	LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE	Look, Inc.	1993-12-23	147	0
K934499	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	GE Medical Systems	1993-12-23	100	0
K933085	GOODMAN BANDAGE	Megadyne Medical Products, Inc.	1993-12-23	183	0
K934724	AESCULAP TROCAR INSTRUMENT SET	Aesculap, Inc.	1993-12-23	83	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