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1991 — Predicate Candidate Screening

4,235 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

88 daysmedian FDA review time

213 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K914407	PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)	Promedex, Inc.	1991-12-31	90	0
K912639	SONICAID TEAM	Oxford Medilog, Inc.	1991-12-31	200	0
K914903	QUICKSTART UREA NITROGEN	Em Diagnostic Systems, Inc.	1991-12-31	60	0
K905068	PTI INTRA-ART (TM) PICK-UP WICKS	Pioneering Technologies, Inc.	1991-12-31	417	0
K914500	OPTI-PLAST 5F PTA CATHETERS, MODIFICATION	Vas-Cath, Inc.	1991-12-31	84	0
K910665	MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED	Ge Medical Systems Information Technologies	1991-12-31	323	0
K913785	CORONET 100	Micro-Shev , Ltd.	1991-12-31	130	0
K914813	THERASTIM	Precision Electronics , Ltd.	1991-12-31	67	0
K913919	UNIVERSAL TERMINAL CAP, 3.2MM	Telectronics Pacing Systems, Inc.	1991-12-31	119	0
K912813	SIRIUS	Pfizer Laser Systems	1991-12-31	194	0
K914413	SPECTACLE FRAMES	Mikado Ca.	1991-12-31	89	0
K913560	STOPCOCK	Graham Medical Products	1991-12-31	144	0
K912257	CHEM-SLEEVE B	Haz-Med, Inc.	1991-12-31	223	0
K914913	GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST	Ideal Medical, Inc.	1991-12-31	60	0
K914425	PYRAMID SUNGLASSES/READING GLASSES	Pyramid	1991-12-31	89	0
K915461	PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES	Phonak, Inc.	1991-12-30	26	0
K911440	RAPI-JECT(R) SYRINGE	David Bull Laboratories, USA, Inc.	1991-12-30	273	0
K914744	SYSMEX NE-1500, MODIFICATION	Toa Medical Electronics USA, Inc.	1991-12-30	69	0
K913625	ELECTROSCOPE MONITOR, EM-1	Electroscope, Inc.	1991-12-30	137	1
K912740	ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)	Visionary Systems, Inc.	1991-12-30	192	0
K913262	AESCULAP SURGICAL ACCESSORIES	Aesculap, Inc.	1991-12-30	160	0
K914962	FUN FLOSS	Fun Floss Co.	1991-12-30	55	0
K915247	NPG III CASTING ALLOY	Aalba Dent, Inc.	1991-12-30	45	0
K915546	PS MEDICAL VENTRICULOSTOMY KIT	Pudenz-Schulte Medical Research Corp.	1991-12-30	19	1
K911599	IMMUNOWELL LYME (P39 RECOMBINANT) TEST	General Biometrics, Inc.	1991-12-30	265	0
K914387	TRANSCERVICAL INTRAUTERINE KIT	Telos Medical Corp.	1991-12-30	90	0
K914374	OSTEO CERCLAGE WIRE	Osteo AG	1991-12-30	90	0
K912713	S-ROM ZT HA PROXIMAL FEMORAL SLEEVE	Joint Medical Products Corp.	1991-12-30	193	0
K910823	PERCUDISC(TM) SYSTEM	Percudisc, Inc.	1991-12-30	307	0
K912780	MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD	Electroscope, Inc.	1991-12-30	189	8
K914614	FRAMES (SPECTACLES) VARIOUS TYPES	Match Optical Co.	1991-12-30	74	0
K914576	KELLER CARDIAC MONITOR MEDIL KMS870	Keller Medical Specialties Products, Inc.	1991-12-30	76	0
K915248	LPG CASTING ALLOY	Aalba Dent, Inc.	1991-12-30	45	0
K912781	ELECTROSHIELD	Electroscope, Inc.	1991-12-30	189	0
K913793	SIMPEX INC. ORAL AND RECTAL THERMOMETERS	Simpex, Inc.	1991-12-30	129	0
K915120	TEF/PLATINUM PISTON	River Medical, Inc.	1991-12-27	44	0
K914324	CAVITY VARNISH PRODUCT	Confi-Dental Products Co.	1991-12-27	92	0
K903644	SERIES 1500 12-LEAD ANALYSIS OPTION	Marquette Electronics, Inc.	1991-12-27	501	0
K915112	MAGNETOM 42 SP,63 SP,IMPACT	Siemens Medical Solutions USA, Inc.	1991-12-27	44	0
K913521	XEMEX TEMPORARY PACING CATHETER A MODIFIED	Zeon Medical Corp.	1991-12-27	143	0
K915118	PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE	Ipax, Inc.	1991-12-27	44	0
K914420	ELISA RUBELLA IGM	Sclavo, Inc.	1991-12-27	85	0
K913387	DIGITRAPPER MARK III	Synectics-Dantec	1991-12-27	151	0
K913129	ANGIOLAZ ANGIOSCOPE CATHETER	Angiolaz, Inc.	1991-12-27	164	0
K913175	MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES	G-C Intl. Corp.	1991-12-27	163	0
K911702	OLYMPUS RETRACTABLE VALVULOTOME	Olympus Corp.	1991-12-27	255	0
K912735	GENESIS UNICOMPARTMENTAL KNEE SYSTEM	Smith & Nephew Richards, Inc.	1991-12-27	190	2
K914482	STOMA MEASURING DEVICE	Biosearch Medical Products, Inc.	1991-12-27	80	0
K915094	VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM	Vortech Data, Inc.	1991-12-27	45	0
K913492	KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM	Kirschner Medical Corp.	1991-12-27	143	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