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

1997 — Predicate Candidate Screening

4,309 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

86 daysmedian FDA review time

269 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K973764	TEMPERATURE DIAGNOSTIC ACCESSORY	New Star Lasers, Inc.	1997-12-31	90	0
K973763	KENDALL CURITY IODOFORM PACKING STRIP	Kendall Healthcare Products Co. Div.Of Tyco Health	1997-12-31	90	0
K971696	SENTINEL RECORDER, MODELS 471/472	Del Mar Avionics	1997-12-30	236	0
K973787	MEDRAD 1.5T EXTREMITY ARRAY	Medrad, Inc.	1997-12-30	85	0
K971663	WELLCOLEX E.COLI O157:H7	Murex Biotech , Ltd.	1997-12-30	238	0
K973833	CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY	Dynarad Corp.	1997-12-30	84	0
K955893	EVERYTIME TRANSFUCER COVER	Amedic AB	1997-12-30	746	0
K971775	INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610	Cardiac Control Systems, Inc.	1997-12-29	230	0
K973862	PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS	Sims Deltec, Inc.	1997-12-29	81	3
K973744	UNICATH SP BI-PLANE (MODEL M269 & M289)	Xre Corp.	1997-12-29	89	0
K971570	EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391	Quinton Electrophysiology Corp.	1997-12-29	244	0
K973736	AESCULAP HILAN MOTOR SYSTEM	Aesculap, Inc.	1997-12-29	89	0
K973806	DUODERM HYDROACTIVE GEL	Convatec, A Bristol-Myers Squibb Co.	1997-12-29	84	0
K973774	CODMAN HAKIM MICRO PRECISION VALVE	Johnson & Johnson Professionals, Inc.	1997-12-29	87	0
K973873	DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1	American Telecare, Inc.	1997-12-29	80	0
K973857	FLOSTAT VASCULAR REPORT GENERATOR (VRG)	Biomedix, Inc.	1997-12-29	81	0
K972258	HI-CARE CLOSED SUCTION SYSTEM	Mallinckrodt Medical	1997-12-29	195	0
K973683	OMEGA 21 SYSTEM	Ebi Electro Biology	1997-12-24	89	0
K973706	DURA-GUARD-DURAL REPAIR PATCH	Bio-Vascular, Inc.	1997-12-24	86	0
K974191	EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE	Yty Industry (Manjung) Sdn Bhd	1997-12-24	44	0
K973730	DURASIL I AND DURASIL II	Hanson Medical, Inc.	1997-12-24	85	0
K971339	INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS	Becton Dickinson Vascular Access, Inc.	1997-12-24	258	0
K973714	VERSYS HIP SYSTEM BEADED HIP PROSTHESIS	Zimmer, Inc.	1997-12-24	86	2
K973729	POWERFLEX PEC IMPLANT	Hanson Medical, Inc.	1997-12-24	85	0
K974110	IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT	Beckman Instruments, Inc.	1997-12-24	54	0
K973761	MICRO-STRIP FOR OPIATE METABOLITES	Microdiagnostics, Inc.	1997-12-24	83	0
K974262	SYSCOS IDC - G, IDC, BSC, IDC - G	Scantibodies Laboratory, Inc.	1997-12-24	41	0
K974425	BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP P	Princeton BioMeditech Corp.	1997-12-24	30	0
K974159	OSOM HCG-URINE TEST MODEL 101	Wyntek Diagnostics, Inc.	1997-12-24	71	0
K973638	N.I.T., INC. NEEDLE GUIDING TEMPLATE	Avid N.I.T., Inc.	1997-12-23	90	0
K963969	INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODE	Indigo Medical, Inc.	1997-12-23	446	0
K971637	COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DIS	Oxoid , Ltd.	1997-12-23	235	0
K973688	DUODERM CONTROL GEL FORMULA BORDER DRESSING	Convatec, Ltd.	1997-12-23	88	0
K974306	SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA	Sangui Biotech, Inc.	1997-12-23	36	0
K973631	LORAD M-III ELITE (M-III E)	Lorad Corp.	1997-12-23	90	0
K973807	DUODERM HYDROACTIVE PASTE	Convatec, A Bristol-Myers Squibb Co.	1997-12-23	78	0
K973719	MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YA	Continuum Biomedical, Inc.	1997-12-23	84	0
K973951	LEVO COMPACT-EASY LCE	Levo USA	1997-12-23	68	0
K973644	FLOSTAT VASCULAR LAB	Biomedix, Inc.	1997-12-23	90	0
K972480	3I BIORESORBABLE FIXATION TACK	Implant Innovations, Inc.	1997-12-23	175	0
K973689	DUODERM HYDROACTIVE DRESSING	Convatec, Ltd.	1997-12-23	88	0
K974048	INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER	Hollister, Inc.	1997-12-23	60	0
K973767	HARMONIC IMAGING WITH CONTRAST	Acuson Corp.	1997-12-23	82	0
K974054	DISTAL CENTRALIZER, EXETER II HIP SYSTEM	Howmedica, Inc.	1997-12-23	57	3
K963817	LEVO MOBIL LCM	Levo USA	1997-12-23	456	0
K973959	OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW	Olicon Imaging Systems, Inc.	1997-12-22	67	0
K971360	SYNTEX	Shinemound Enterprise, Inc.	1997-12-22	255	0
K974516	ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE	Endolap, Inc.	1997-12-22	20	0
K973988	RDI HOMOGENEOUS HDL CHOLESTEROL TEST	Reference Diagnostics, Inc.	1997-12-22	62	0
K973632	DUODERM CGF CONTROL GEL FORMULA DRESSING	Convatec, A Division of E.R. Squibb & Sons	1997-12-22	89	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