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

1998 — Predicate Candidate Screening

3,775 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

79 daysmedian FDA review time

230 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K984458	DEPUY ACE SPIDER PLATE	Depuy Ace Medical Co.	1998-12-31	16	0
K981680	ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS	Dayton Water Systems	1998-12-31	232	0
K983770	'RAPID DRUG SCREEN' 9-PANEL	American Bio Medica Corp.	1998-12-31	66	0
K983529	INSTATRAK 3000	Visualization Technology, Inc.	1998-12-31	84	6
K983976	METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM	Metagen, LLC	1998-12-30	51	0
K984342	ANTERIOR CERVICAL PLATING SYSTEM	United States Surgical, A Division of Tyco Healthc	1998-12-30	26	0
K982549	RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC	Radionics, Inc.	1998-12-30	162	0
K983519	COMFEEL SEASORB DRESSING	Coloplast Corp.	1998-12-30	83	1
K983267	DIGORA FOR WINDOWS 2.0	Orion Corporation Soredex	1998-12-30	104	0
K984431	ULTIMA AIRFLOW PRESSURE SENSOR	Braebon Medical Corp.	1998-12-30	19	0
K982142	MOUNTABLE ENDOSCOPIC KNIFE	A.M. Surgical, Inc.	1998-12-30	196	0
K983873	SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM	Syntec Scientific Corp.	1998-12-30	58	0
K983571	SYSTEM U3 FOR TETRACYCLINE	Ab Biodisk	1998-12-30	78	0
K984414	XRE COLLIMATOR WITH SPECTRAL FILTER	Trex Medical Corp.	1998-12-30	20	0
K984378	DEPUY ACROMED MOSS SPINAL SYSTEM	Depuy, Inc.	1998-12-30	23	0
K983622	BODYFORM THORACO-LUMBAR FIXATION SYSTEM	Theken Surgical,Llc	1998-12-30	76	0
K983761	AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5	Aaron Medical Industries	1998-12-30	65	0
K983055	RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003	Guidant Corp.	1998-12-30	120	0
K983747	SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II	Beckman Coulter, Inc.	1998-12-30	68	0
K982791	ROCS TPS	Radiation Oncology Computer Systems	1998-12-30	142	0
K984401	NEUROMAG VECTORVIEW	Philips Medical Systems (Cleveland), Inc.	1998-12-30	21	0
K984164	JELBOND NP	Jelenko Co.	1998-12-29	39	0
K974332	VARIABLE PRESSURE SYRINGE PUMP	Alaris Medical Systems, Inc.	1998-12-29	406	0
K983535	THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING S	Hans Hermann GmbH	1998-12-29	81	0
K982337	CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER	Haidylena Medical Egypt	1998-12-29	176	0
K983990	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY	Ortho-Clinical Diagnostics, Inc.	1998-12-29	50	0
K983952	GREINER VACUETTE BLOOD COLLECTION TUBE	Greiner Meditech, Inc.	1998-12-28	53	2
K980878	PULMOTRACK,MODEL 1010	Karmel Medical Acoustic Technologies , Ltd.	1998-12-28	294	0
K983484	DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE	Empi	1998-12-28	84	0
K982562	BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER	Integrated Orbital Implants, Inc.	1998-12-28	158	2
K984535	PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION	Puritan Bennett Corp.	1998-12-28	7	1
K983921	AUTOSTAT II ENA SCREEN ELISA	Cogent Diagnotics , Ltd.	1998-12-28	54	0
K983811	UNIPOLAR OPTICAL BIOPSY FORCEPS	Olympus Winter & Ibe GmbH	1998-12-24	57	0
K983559	BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR	Icu Medical, Inc.	1998-12-24	72	0
K983366	TRIP TONOMETRY CATHETER, 16F	Datex-Engstrom, Inc.	1998-12-23	90	0
K984211	MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLAS	Medscand AB	1998-12-23	29	0
K984359	AIA-PACK TROPONIN I ASSAY	Tosoh Medics, Inc.	1998-12-23	16	0
K983716	VITALCARE DISPOSABLE VAGINAL SPECULUM	Vitalcare Group, Inc.	1998-12-23	63	0
K984145	OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT	Olympus Diagnostica GmbH	1998-12-23	34	0
K983374	AGATHA-A-H2010	Midian Intl.	1998-12-23	89	0
K982897	POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LAB	Pt. Maja Agung Latexindo	1998-12-23	128	0
K984384	6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL	Thermo Bioanalysis Corp.	1998-12-23	15	0
K983486	SYSTEM U3 FOR NORFLOXACIN	Ab Biodisk	1998-12-23	79	0
K983516	TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A	Toshiba America Medical Systems, In.C	1998-12-23	77	0
K984019	POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CO	Kossan Latex Industries(M)Sdn Bhd	1998-12-23	41	0
K984020	POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELI	Kossan Latex Industries(M)Sdn Bhd	1998-12-23	41	0
K984500	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	Cordis Corp.	1998-12-23	6	1
K982832	PROGUARD, RR-1, RR-2	Emerson & Co. Srl	1998-12-23	133	0
K983514	POSITRON OPTION, MODEL NSCO-050A	Toshiba America Medical Systems, In.C	1998-12-23	77	0
K983714	SOLARTEC SOURCE 270, MODEL # 90123	Cogent Light Technologies, Inc.	1998-12-23	63	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