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1989 — Predicate Candidate Screening

5,030 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

88 daysmedian FDA review time

202 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days
K896962	TINY HALOGEN EXAM LIGHT	Jedmed Instrument Co.	1989-12-29	14
K896105	EVOLUTION HIP SYSTEM	Dow Corning Wright	1989-12-29	70
K891986	MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE	Mark One Healthcare Products	1989-12-29	276
K895917	CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI	Coulter Immunology	1989-12-29	80
K890349	SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN	Becton Dickinson Immunocytometry Systems	1989-12-29	339
K896643	HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015	Medix Biotech, Inc.	1989-12-29	35
K896479	ORTHO* RUBELLA-G ANTIBODY ELISA TEST	Ortho Diagnostic Systems, Inc.	1989-12-29	46
K895864	MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP	Lasag AG	1989-12-29	87
K894608	MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM	Micro-Shev , Ltd.	1989-12-29	164
K894949	SQA	United Medical Systems, Inc.	1989-12-29	148
K885221	MULTILUMEN CENTRAL VENOUS CATHETER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989-12-28	373
K896058	GRASPING FORCEPS	Annex Medical, Inc.	1989-12-28	71
K895426	AMBULATORY INFUSION PUMP	Bionica, Inc.	1989-12-27	113
K895012	E-Z-EM VACUUM ASPIRATION SYRINGE	E-Z-Em, Inc.	1989-12-27	141
K896008	MODEL 6500 MERCURY ARC LIGHT SOURCE	Medical Dynamics, Inc.	1989-12-27	75
K895865	SERENE WRAP	Byron Medical	1989-12-27	86
K895516	CAVITY DRAINAGE CATHETERIZATION SET, CS-01600	Arrow Intl., Inc.	1989-12-27	106
K895291	IV DISPESNSING SPIKE	The Medi-Dose Group	1989-12-27	124
K895465	AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE	Baxter Healthcare Corp	1989-12-27	107
K896801	LAP SPONGE	Westmark, Sterile Packing Systems, Inc. (Sps)	1989-12-27	26
K896792	SURGICAL SKIN MARKER	Westmark, Sterile Packing Systems, Inc. (Sps)	1989-12-27	26
K895756	MIKRO-AQUAPURATOR	Mikro-Tek Laboratories	1989-12-27	92
K894423	ACC.U.DIAL	Exocell, Inc.	1989-12-27	163
K896641	MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT	Medix Biotech, Inc.	1989-12-27	33
K896390	WILSON-COOK ESOPHAGEAL PROSTHESIS	Wilson-Cook Medical, Inc.	1989-12-27	51
K896774	STREAMLINE VASCULAR ACCESS DEVICE	Menlo Care, Inc.	1989-12-27	26
K896145	ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY	Serono-Baker Diagnostics, Inc.	1989-12-27	65
K896802	MAGNET PAD	Westmark, Sterile Packing Systems, Inc. (Sps)	1989-12-27	26
K896003	LATEX EXAMINATION GLOVES	Jiea Chao Ent. Co., Ltd.	1989-12-27	75
K896006	DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095	Baxter Healthcare Corp	1989-12-27	75
K896831	ALISUN SUNTANNING BED	Alisun America, Ltd.	1989-12-27	22
K896111	FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB	Fresenius USA, Inc.	1989-12-27	65
K895943	NORMAL AND ABNORMAL CONTROL SERA	Sclavo, Inc.	1989-12-27	77
K896803	CLOSED WOUND RESERVOIR	Westmark, Sterile Packing Systems, Inc. (Sps)	1989-12-27	26
K895884	BANDAGE REMOVAL STRIP	Kut-Guard, Inc.	1989-12-27	83
K895290	CHEMO-SPIKE RECONSTITUTION DEVICE	The Medi-Dose Group	1989-12-27	124
K893461	LATEX EXAMINATION GLOVES	Zhum Heng Development , Ltd.	1989-12-27	238
K896191	SUNTANNING BED, INC. T12 UVA TANNING LAMPS	Sunbronze	1989-12-27	62
K895689	LIFEPORT VASCULAR ACCESS PORT	Strato Medical Corp.	1989-12-27	96
K895139	CLINISTAT HDL CHOLESTEROL REAGENT TEST	Heraeus Kulzer, Inc.	1989-12-27	133
K896589	MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP	Optik	1989-12-27	36
K896584	ARTHROSCOPIC TUBING SHEATH	Origin Medsystems, Inc.	1989-12-27	36
K895755	MIKRO-LAVAGE-1	Mikro-Tek Laboratories	1989-12-27	92
K895802	NON CONSTRAINED TOTAL SHOULDER SYSTEM	Orthopaedic Medical Group, Inc.	1989-12-27	90
K895883	BECKMAN MA MICROALBUMIN REAGENT KIT	Beckman Instruments, Inc.	1989-12-27	83
K896593	BECTON DICKINSON RATE INFUSER II SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989-12-27	36
K895876	RAMVAC DENTAL VACUUM SYSTEM	Ramvac Corp.	1989-12-26	82
K896685	BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM	Bausch & Lomb, Inc.	1989-12-26	28
K895877	RAMCLEAN DENTAL VACUUM LINE CLEANER	Ramvac Corp.	1989-12-26	82
K895815	MICROTEK TOTAL OSSICULAR PROTHESIS	Microbio-Medics, Inc.	1989-12-26	88

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