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

1985 — Predicate Candidate Screening

4,483 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

59 daysmedian FDA review time

168 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days
K854001	CERTI-FORM	Beltone Electronics Corp.	1985-12-31	92
K854043	AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B	Teledyne Avionics Div. of Teledyne	1985-12-31	90
K854363	SARATOGA SCT HEATED HUMIDIFICATION SYSTEM	Saratoga Medical Instrumentation, Inc.	1985-12-31	63
K851972	DIASONICS ADA400 ADVANCED DIGITAL ARRAY	Diasonics, Inc.	1985-12-31	238
K854052	CSM MEDIUM	Northern Scientific, Inc.	1985-12-31	89
K840571	EKG 503A	Bosch Hearing Instruments, Inc.	1985-12-30	691
K854402	THE NEW MCINTYRE I.A. HANDPIECE	Microsurgical Technology, Inc.	1985-12-30	60
K852459	HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175	Healthteam	1985-12-30	203
K854422	SERIES 25 SLIMLINE CRYO PROBES	Keeler Instruments, Inc.	1985-12-30	56
K853990	OSM3 HEMOXIMETER	Radiometer America, Inc.	1985-12-30	94
K852653	HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115	Healthteam	1985-12-30	203
K843717	VIRATEK SMALL PARTICLE AEROSOL GENERAT	Viratek, Inc.	1985-12-30	465
K840569	EKG 501 A	Bosch Hearing Instruments, Inc.	1985-12-30	691
K854708	DART CK-MB REAGENT SYSTEM	Coulter Electronics, Inc.	1985-12-30	38
K854611	RAMP URINE HCG ASSAY	Monoclonal Antibodies, Inc.	1985-12-30	42
K852457	HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165	Healthteam	1985-12-30	203
K854401	THE NEW MOBILE TIP MCINTYRE CANNULA	Microsurgical Technology, Inc.	1985-12-30	60
K852458	HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145	Healthteam	1985-12-30	203
K853217	QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES	Quantum Medical Systems, Inc.	1985-12-30	151
K854411	KEELER-COMPACT CRYO SYSTEM	Keeler Instruments, Inc.	1985-12-30	59
K842066	PERI-GUARD PERICARDIAL PATCH	Genetic Laboratories, Inc.	1985-12-30	616
K854764	LECTROSTILL DISTILLED WATER U.S.P.	Electrified Companies, Inc.	1985-12-30	33
K854739	AMERICAN STERILE SURGICAL ABSORBENT TOWEL	American Hospital Supply Corp.	1985-12-27	32
K854375	COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR	CooperVision, Inc.	1985-12-27	58
K853967	HI-TECH LAB MODEL CONCHA ALL IN EAR	Hi-Tech Laboratories, Inc.	1985-12-27	92
K854225	ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS	Advanced Medical Technology, Inc.	1985-12-27	70
K854495	GRESCO N.P. DENTAL ALLOY	Gresco Products, Inc.	1985-12-27	45
K853804	VICON (MODIFICATION)	Oxford Metrics, Inc.	1985-12-27	107
K854827	LINK CORTICAL SCREWS	Link America, Inc.	1985-12-27	24
K854826	LINK CANCELLOUS SCREWS	Link America, Inc.	1985-12-27	24
K852178	EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS	American Omni Medical, Inc.	1985-12-27	221
K854051	MODULAR POWER BASE	Everest & Jennings, Inc.	1985-12-27	85
K853257	SPECULITE DISPOSABLE VAGINAL LIGHT	Trylon Associates, Ltd.	1985-12-27	147
K854054	PLACIDO DISC	Cutler Medical Instruments	1985-12-27	85
K854347	HYBRID POINTS	Shofu Dental Corp.	1985-12-27	59
K854116	PHACO PACKS, 1A PACKS & PACK COMPONENTS	Medical Corp. of America	1985-12-27	80
K853916	P.M. HIP-FEMORAL PROSTHESIS	Advanced Biosearch Assn.	1985-12-27	95
K854153	MARATHON POWER DRIVE-WHEELCHAIR	Everest & Jennings, Inc.	1985-12-27	77
K854657	INTRACRANIAL PRESSURE MONITORING CUP CATHETERS	Cordis Corp.	1985-12-27	37
K854634	BARD PARKER THORACIC VENT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-12-27	38
K852656	MODEL M HEARING AID	Magnatone Hearing Aid Corp.	1985-12-27	186
K852522	SATALEC SERVOTOME	Spelna, Inc.	1985-12-27	196
K854285	GDC 1453 CASTING ALLOY	Deringer-Ney, Inc.	1985-12-27	63
K854147	BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL	Battle Creek Equipment Co.	1985-12-27	77
K854490	IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES	American Micro Scan	1985-12-27	45
K854186	IN VITRO TEST DETERMINATION OF SGPT(ALT)	Clinical Data, Inc.	1985-12-25	71
K854857	SCALPEL, ONE-PIECE, DISPOSABLE	Medelec Intl. Corp.	1985-12-24	19
K854859	BLADES, SCALPEL STAINLESS STEEL	Medelec Intl. Corp.	1985-12-24	19
K854262	MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY	Meadox Surgimed, Inc.	1985-12-24	62
K854892	RULER	Euro-Med Intl.	1985-12-24	18

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