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

1986 — Predicate Candidate Screening

4,347 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

41 daysmedian FDA review time

133 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days
K864715	EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93	Em Diagnostic Systems, Inc.	1986-12-31	28
K864713	CHLORIDE REAGENT	Sigma Diagnostics, Inc.	1986-12-31	28
K864906	ALANINE AMINO TRANSFERASE ALT/SGPT	Tech-Co, Inc.	1986-12-31	16
K864776	A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS	Bartels Immunodiagnostic Supplies, Inc.	1986-12-31	23
K864303	QKO (TM) AMYLASE B-HA	Wako Chemicals USA, Inc.	1986-12-31	61
K863580	DERMATEC TRANSPARENT FILM DRESSING	Dermatec, Inc.	1986-12-31	125
K863069	MAGNESIOMETER	J. D. Assoc.	1986-12-31	141
K864634	AP1 COLORIMETER	Awareness Technology, Inc.	1986-12-31	36
K864236	SYNCHRON CX3	Beckman Instruments, Inc.	1986-12-31	64
K864939	BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT	Beckman Instruments, Inc.	1986-12-31	15
K864892	ELLISON ARTHROSCOPY CHEATER	Buckman Co., Inc.	1986-12-30	15
K864570	PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME	Dongkuk Techco Rubber Industries	1986-12-30	40
K864495	MEDSURG VASCULAR ACCESS PORT INFUSION TRAY	Medsurg Industries, Inc.	1986-12-30	46
K864292	DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY	Eye-Ko, Inc.	1986-12-29	59
K863736	FMS MODEL 110	Flir Medical Systems	1986-12-29	97
K864777	MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC	Mac Lee Medical Products	1986-12-29	21
K864880	COLLINS POSITIONING DEVICE	Orthopedic Systems, Inc.	1986-12-29	17
K864584	FLUOROVISION CONTRAST ENHANCER	Digivision, Inc.	1986-12-29	39
K864639	REUSABLE SURGICAL KERATOSCOPE	Jedmed Instrument Co.	1986-12-29	33
K864781	MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC	Mac Lee Medical Products	1986-12-29	21
K864630	KC/EMG DIAGNOSTIC ELECTROMYOGRAPH	Chattanooga Group, Inc.	1986-12-29	34
K863237	HYDROXYLAPATITE BONE GRAFT MATERIAL	Richards Medical Co., Inc.	1986-12-29	130
K864779	MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC	Mac Lee Medical Products	1986-12-29	21
K863780	ADA-1000 (ADVANCED DIGITAL ARRAY)	Diasonics, Inc.	1986-12-29	94
K864284	MUSCLE MASTER (MEDIUM VOLTAGE STIMULATOR)	Modern Systems Technology, Inc.	1986-12-29	60
K864778	MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC	Mac Lee Medical Products	1986-12-29	21
K864881	ARTHROSCOPIC ANKLE HOLDER	Orthopedic Systems, Inc.	1986-12-29	17
K864558	U66 EMS	Suntec Health & Fitness Group, Inc.	1986-12-29	59
K864747	VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES	Jms Co., Ltd.	1986-12-29	24
K864653	MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS	Rich-Mar Corp.	1986-12-29	31
K864264	TRICOTEX WOUND CONTACT LAYER DRESSING	Smith & Nephew, Inc.	1986-12-29	61
K864263	NEOPROBE PORTABLE RADIOISOTOPE DETECTOR	Neoprobe Corp.	1986-12-29	61
K864076	HERCON ANTISEPTIC TRANSPARENT DRESSING	Hercon Laboratories Corp.	1986-12-29	70
K864764	CULTURIA MACCONKEY-MUG/CLED SYSTEMS	Clinical Convenience Products, Inc.	1986-12-29	24
K864676	HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM	American V. Mueller	1986-12-29	27
K864138	MINIMED MODEL 404-S EXTERNAL INFUSION PUMP	Medtronic Minimed	1986-12-29	69
K863970	MLC ENDOTHELIAL CELL COUNTER	Mlc Technologies	1986-12-29	76
K864625	MYOPAC (TM), MODEL 9600	Medical Devices, Inc.	1986-12-29	34
K864788	EXACTECH TOTAL HIP INSTRUMENTS	Exactech, Inc.	1986-12-29	21
K864550	CARETEX SHOE COVERS	James River Corp.	1986-12-24	35
K864918	HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR	Health Products, Inc.	1986-12-24	8
K864801	THE KEYMED HI-LIGHT 250 LIGHT SOURCE	Keymed, Inc.	1986-12-24	15
K863239	FASCICULATED BOAT ROD	The Deca Co.	1986-12-24	124
K863271	FASCICULATED S ROD	The Deca Co.	1986-12-24	121
K864291	HIGH FREQUENCY NEEDLE-TYPE EPILATOR	Multi-Channel Epilator	1986-12-24	54
K864804	CLOWARD DISPOSABLE ARMRESTS AND FACE REST	Surgical Equipment International, Inc.	1986-12-24	15
K864184	MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN	Mcghan Medical Corp.	1986-12-24	58
K864846	RADIOGRAPHIC - LEG SECTION	American Sterilizer Co.	1986-12-24	14
K863215	FASCICULATED I ROD	The Deca Co.	1986-12-24	126
K864185	MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN	Mcghan Medical Corp.	1986-12-24	58

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