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

2004 — Predicate Candidate Screening

3,373 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

64 daysmedian FDA review time

210 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K041125	MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM	Masep Med Science & Tech. Development (Shenzhen) C	2004-12-30	244	0
K042221	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Barco NV Barcoview	2004-12-30	135	0
K043230	VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM	bioMerieux, Inc.	2004-12-30	38	0
K033210	BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET	Bioteque Corp.	2004-12-30	454	0
K043397	MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE	Becton, Dickinson & CO	2004-12-29	19	0
K042705	DISPOSABLE NON-ADHESIVE SPO2 SENSORS	Elekon Industries U.S.A., Inc.	2004-12-29	90	0
K041407	TITANIUM MESH IMPLANT	Interpore Cross Intl.	2004-12-29	216	0
K042414	VISIOPLAST ACRYLIC RESIN	Tecres	2004-12-29	113	0
K043068	DIFOTI USB 2.0 SYSTEM	Electro-Optical Sciences, Inc.	2004-12-29	51	0
K042713	FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5	Spine Next America Corporation	2004-12-29	90	0
K043481	MODIFICATION TO: ZILVER 635 BILIARY STENT	Cook, Inc.	2004-12-29	14	0
K041652	ACUPUNCTURE NEEDLES	C.A.I. Industries Corp.	2004-12-29	195	0
K030526	PEDIGUARD NERVE DETECTOR SYSTEM	Spine Vision, Inc.	2004-12-29	679	0
K043378	DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRAT	Drew Scientific , Ltd.	2004-12-29	21	0
K043162	PMP4 OXY PRO	Card Guard Scientific Survival , Ltd.	2004-12-29	43	0
K043561	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Medtronic Sofamor Danek	2004-12-29	2	0
K043211	ONLINE DAT BARBITURATES PLUS	Roche Diagnostics Corp.	2004-12-29	40	0
K042916	WATCH PAT 100S	Itamar Medical	2004-12-29	69	0
K042714	FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4	Spine Next America Corporation	2004-12-29	96	0
K042975	AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II	Ameditech, Inc.	2004-12-29	62	3
K043167	PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 902	Phamatech, Inc.	2004-12-29	43	0
K042381	CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508	Acumen Medical, Inc.	2004-12-28	118	0
K042478	CAPSULE TENSION RING INSERTER, MODEL 7-810	Duckworth & Kent, Ltd.	2004-12-28	106	0
K042930	SPACEVISION CAGE SYSTEM	Spine Vision, Inc.	2004-12-28	67	0
K043343	MODIFICATION TO: CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek	2004-12-28	22	0
K043403	CEMEX SYSTEM GENTA FAST BONE CEMENT	Exactech, Inc.	2004-12-28	18	0
K042902	HERBERT ULNAR HEAD PROSTHESIS SYSTEM	Stuckenbrock Medizintechnik GmbH	2004-12-27	68	0
K032434	CLINICAL ELECTRONIC THERMOMETER	Cotronic Manufacturing	2004-12-27	509	0
K042362	MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30,	Diagnostic Chemicals , Ltd.	2004-12-27	118	0
K042288	UNICRYL	United Medical Industries Co. , Ltd.	2004-12-27	125	0
K042911	CEMENTEK LV	Teknimed, S.A.	2004-12-27	67	0
K040974	GLUCOSE OXIDASE, GLUCOSE	Genchem, Inc.	2004-12-27	257	0
K040977	GENCHEM ELECTROLYTE BUFFER	Genchem, Inc.	2004-12-27	257	0
K043404	MODIFICATION TO T2 PROXIMAL HUMERAL NAIL	Howmedica Osteonics Corp.	2004-12-27	17	0
K040972	CALCIUM, AZO DYE REAGENT	Genchem, Inc.	2004-12-27	257	0
K042947	PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003	Arthrocare Corp.	2004-12-27	62	0
K042329	SALICYLATE-SL ASSAY	Diagnostic Chemicals , Ltd.	2004-12-27	122	1
K040976	GENCHEM CREATININE REAGENT	Genchem, Inc.	2004-12-27	257	0
K040975	GENCHEM CO2 ACID REAGENT	Genchem, Inc.	2004-12-27	257	0
K040973	BUN REAGENT	Genchem, Inc.	2004-12-27	257	0
K041078	SURGPLAN AND PANPLAN	Imaging Sciences Intl., Inc.	2004-12-23	241	0
K043241	LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER	Astra Tech, Inc.	2004-12-23	30	0
K043202	OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279	Olympus America, Inc.	2004-12-23	35	0
K040778	TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHE	Tanita Corp. of America	2004-12-23	272	0
K043237	VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXAC	bioMerieux, Inc.	2004-12-23	31	0
K043086	SOMATOM RESPIRATORY GATING	Siemens Medical Solutions USA, Inc.	2004-12-23	45	0
DEN040012	AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	Affymetrix, Inc.	2004-12-23	50	0
K043381	INFINIA LIGHTSPEED	Ge Medical Systems F.I. Haifa	2004-12-23	14	0
K030295	LTU-904 PORTABLE LASER THERAPY UNIT	Riancorp Pty, Ltd.	2004-12-23	695	0
K043318	MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY	Roche Diagnostics Corp.	2004-12-23	21	1

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