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

1994 — Predicate Candidate Screening

5,762 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

124 daysmedian FDA review time

480 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K944386	R&D BATTERIES PART NOS. 5354 AND 5150	R & D Batteries, Inc.	1994-12-30	114	0
K932288	NEONATAL BREATHING CIRCUIT MODIFICATION	Simplex Medical Systems, Inc.	1994-12-30	599	0
K933410	IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PE	Best Industries	1994-12-30	533	0
K944984	EMSEE LABS MODEL S	Emsee Lab of Florida	1994-12-30	79	0
K944294	R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102	R & D Batteries, Inc.	1994-12-30	119	0
K943800	2D,3D, TOF MR ANGIOGRAPHY	Hitachi Medical Systems America, Inc.	1994-12-30	149	0
K943675	ENTERAL DELIVERY SETS WITH HYDRATION PORT	Clintec Technologies, Inc.	1994-12-30	157	0
K934732	PELVIC EXAM TRAY	Medcare Custom Packaging, Inc.	1994-12-30	457	0
K944777	ORION PPM, PP, PP-D	Rexton, Inc.	1994-12-30	94	0
K940119	ROYAL MARSDEN GOLD GRAIN GUN	Best Industries	1994-12-30	354	0
K931473	IMPACT MODEL 753	Impact Instrumentation, Inc.	1994-12-30	646	0
K944985	EMSEE LABS MODE M	Emsee Lab of Florida	1994-12-30	79	0
K940191	ELECTROSURGICAL LOOP ELECTRODE	National Wire & Stamping, Inc.	1994-12-30	351	0
K933156	DATEX AS/3 PATIENT MONITOR	Datex Division Instrumentarium Corp.	1994-12-30	549	0
K933384	BARD HYSTERO-FLO II PUMP	Davol Inc., Sub. C. R. Bard, Inc.	1994-12-30	536	0
K943392	THERA-FLOW GRADIENT SEQUENTIAL PUMP	Meds Systems, Inc.	1994-12-30	169	0
K935688	AN-10S ANDERSEN TUBE WITH STYLET	H.W. Andersen Products, Inc.	1994-12-30	396	0
K944986	EMSEE LABS MODEL C	Emsee Lab of Florida	1994-12-30	79	0
K940121	IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS	Best Industries	1994-12-30	354	0
K945159	SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE	Scimed Life Systems, Inc.	1994-12-30	70	0
K944555	ENDOSCOPE	United States Surgical, A Division of Tyco Healthc	1994-12-30	105	0
K945284	TRUJECT	Clive Craig Co.	1994-12-29	59	0
K945401	WHITE STAR	Jeneric/Pentron, Inc.	1994-12-29	56	0
K945712	VERABOND V	Aalba Dent, Inc.	1994-12-29	38	0
K940950	KAVO SYSTEMATICA 1060	Kavo America	1994-12-29	304	0
K921682	ZINETICS AMC	Zinetics Medical, Inc.	1994-12-29	995	0
K945910	QUEST 2 AND 20	Aalba Dent, Inc.	1994-12-29	27	0
K944086	CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS	Beckman Instruments, Inc.	1994-12-29	177	0
K944075	CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST	Beckman Instruments, Inc.	1994-12-29	177	0
K945539	OPTIGUARD	Sybron Dental Specialties, Inc.	1994-12-29	45	0
K945723	OPULENT 76 AND 83	Aalba Dent, Inc.	1994-12-29	38	0
K945190	STERRAD CHEMICAL INDICATOR TAPE	Advanced Sterilization Products	1994-12-29	66	0
K940091	INNOVA VAGINAL EMG SENSING ELECTRODE	Empi	1994-12-29	356	0
K940261	LYNX LOW-SPEED HANDPIECE	Mti Precision Products	1994-12-29	342	1
K944271	DENTAL OPERATIVE UNIT ACCESORIES	Dci Intl.	1994-12-29	121	0
K945867	R&D PART 5518, 5306, 5315 AND 5457	R & D Batteries, Inc.	1994-12-29	28	0
K943643	STAT PROFILE ULTRA 11 ANALYZER	Nova Biomedical Corp.	1994-12-29	155	0
K945713	VERABOND II	Aalba Dent, Inc.	1994-12-29	38	0
K945577	GUARDIAN II GLOVE	Guardian Group, Inc.	1994-12-29	45	0
K945244	PULP CANAL SEALER EWT	Sybron Dental Specialties, Inc.	1994-12-29	63	0
K945364	DYRACT(TM) MATERIAL	Denstply Detrey-Dedent	1994-12-29	69	0
K942997	ALKALINE PHOSPHATASE (ALKP) QVET	Prisma Systems	1994-12-29	189	0
K933796	EEG NEEDLE ELECTRODE	Cadwell Laboratories, Inc.	1994-12-29	512	0
K943729	DYE CHECK STRIPS 545-630	Awareness Technology, Inc.	1994-12-29	149	0
K945769	TOTAL ETCH GEL	Dentsply Intl.	1994-12-29	57	0
K945714	VERABOND III	Aalba Dent, Inc.	1994-12-29	38	0
K943042	BUN QVET	Prisma Systems	1994-12-29	185	0
K944056	AUTO-LYTE METHADONE DIA	Solarcare Technologies Corp,Inc.	1994-12-29	132	0
K942964	LACTATE DEHYDROGENASE QVET	Prisma Systems	1994-12-29	189	0
K933873	CONCEPT UNIVERSAL PUMP SYSTEM	Linvatec Corp.	1994-12-29	507	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