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

1990 — Predicate Candidate Screening

4,721 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

78 daysmedian FDA review time

200 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K903946	COOL CAST(R)	Hawthorne Products, Inc.	1990-12-31	126	0
K904560	VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES	Valleylab, Inc.	1990-12-31	87	0
K905655	NONABSORBABLE POLYPROPYLENE SURGICAL MESH	United States Surgical, A Division of Tyco Healthc	1990-12-31	13	0
K905671	BRODA WHEELCHAIR	Broda Ent., Inc.	1990-12-31	13	0
K905299	ROMFLEX REHABILITATION EQUIPMENT	Dyna Flex, Intl.	1990-12-31	33	0
K905576	LINGRAPHICA VISUAL LANGUAGE PROSTHESIS	Tolfa Corp.	1990-12-31	19	0
K903117	ORION STERILE OR TOWELS	Orion Life Systems, Inc.	1990-12-31	168	0
K905271	PRIDE SPIRIT	Pride Health Care, Inc.	1990-12-31	40	0
K904795	FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1990-12-31	73	0
K905684	ALKALINE PHOSPHATASE	Amresco, Inc.	1990-12-28	9	0
K905003	BIO-GUARD SHAVE PREP TRAY	Network Medical Systems, Inc.	1990-12-28	51	0
K904644	EUROSUN MODELS - ES-2400, ES-VHO AND ES-16	Eurosun, Inc.	1990-12-28	78	0
K905203	COAGULATION REFERENCE PLASMA, NORMAL	Medical Diagnostic Technologies, Inc.	1990-12-28	38	0
K904545	FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET	Valleylab, Inc.	1990-12-28	85	0
K905015	SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE	Surgitek	1990-12-28	51	0
K904472	GLASSMAN STONE EXTRACTION SET	Wilson-Cook Medical, Inc.	1990-12-28	88	0
K905483	MEMORYMATE MODEL 8270 ITE HEARING AID	3M Company	1990-12-28	22	0
K903844	OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING	Cordis Corp.	1990-12-28	129	0
K903961	MEASLES IGG MICROASSAY	Diamedix Corp.	1990-12-28	122	0
K904557	MICROFLO	Life-Tech Intl., Inc.	1990-12-28	84	0
K903300	RESP-EZ(TM) RESPIRATORY MONITORING BELT	Epm Information Systems, Inc.	1990-12-28	157	0
K904586	PALEX IRRIGATION SET	Palex Intl. SA	1990-12-28	80	0
K904927	HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM	Hennson Intl., Inc.	1990-12-28	58	0
K904403	BARD AMBULATORY PCA DRUG DELIVERY SYSTEM	C.R. Bard, Inc.	1990-12-28	94	0
K904997	ABUSCREEN ONLINE TM FOR OPIATES	Roche Diagnostic Systems, Inc.	1990-12-27	50	0
K904680	THERATEK GROUP EXCHANGE CATHETER	Dow Corning Wright	1990-12-27	73	0
K904336	NEW COBE SATURATION/HEMATOCRIT MONITOR	Cobe Laboratories, Inc.	1990-12-27	98	0
K903376	ACROMED SACRAL SCREW	Acromed Corp.	1990-12-27	150	0
K903113	CGA-112 COPING GOLD ALLOY	Minimatic Implant Technology	1990-12-27	167	0
K905544	MAGNESIUM REAGENT	Amresco, Inc.	1990-12-27	16	0
K903083	NEONATAL VENTILATOR CIRCUIT	Hudson Respiratory Care, Inc.	1990-12-27	168	0
K904034	TEMPORARY DENTAL CEMENT	Medical Device Inspection Co., Inc.	1990-12-27	118	0
K905197	THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM	Ormco Corp.	1990-12-27	37	0
K905697	POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE	Impact Instrumentation, Inc.	1990-12-27	3	0
K905147	ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS	Hewlett-Packard Co.	1990-12-27	42	0
K905592	AFFINITY FSH TEST SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1990-12-27	14	0
K904039	REFLECTANCE SENSOR (RS-10)	Nellcor, Inc.	1990-12-27	114	0
K904674	CENTRAL VENOUS PRESSURE MANOMETER	Medex, Inc.	1990-12-27	76	1
K903580	MICRO-MISTER	Bp , Ltd.	1990-12-27	141	0
K896903	FIRST MEDIC MODEL 510	Spacelabs, Inc.	1990-12-27	384	0
K904524	CAPTIA(R) SYPHILIS M, MODIFICATION	Mercia Diagnostics , Ltd.	1990-12-26	90	1
K904569	EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS	Syva Co.	1990-12-26	78	0
K903965	STATPAL BLOOD GAS MONITORING SYSTEM	Ppg Industries, Inc.	1990-12-26	120	0
K905521	CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION	Microgenics Corp.	1990-12-26	19	0
K904082	CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST	Cholestech Corp.	1990-12-26	112	1
K905222	CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0	Nuccardiac Software, Inc.	1990-12-26	36	0
K904612	I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)	Medical Technical Products	1990-12-26	76	0
K904081	GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM	Heraeus Kulzer, Inc.	1990-12-26	112	0
K904570	EMIT(R) II CANNABINOID 20 NG ASSAY	Syva Co.	1990-12-26	78	0
K905622	COULTER DIRECT BILLRUBIN REAGENT	Coulter Electronics, Inc.	1990-12-26	12	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