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

2005 — Predicate Candidate Screening

3,156 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

63 daysmedian FDA review time

191 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K053303	CARDIOCOM COMMANDER III	Cardiocom, LLC	2005-12-30	32	0
K053440	AMPLATZER SIZING BALLOON II	Aga Medical Corp.	2005-12-30	21	2
K052795	PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30	Philips Medizin Systeme Boeblingen GmbH	2005-12-30	88	1
K052988	CAAS	Pie Medical Imaging BV	2005-12-30	67	0
K053132	WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23	Wako Chemicals USA, Inc.	2005-12-30	52	0
K052320	ENCORE CLP OFFSET TOTAL HIP SYSTEM	Encore Medical Corporation	2005-12-30	127	1
K053304	COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM	Cardiocom, LLC	2005-12-30	32	0
K053020	TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM	Bayer Healthcare, LLC	2005-12-30	65	3
K053016	WIRELESS PHYSIOLOGIC MONITORING SYSTEM	Edwards Lifesciences, LLC	2005-12-30	65	0
K053432	EKOS MICRO-INFUSION SYSTEM	Ekos Corp.	2005-12-30	21	0
K051603	STRYKER INJECTABLE CEMENT	Stryker Leibinger Micro Implants	2005-12-30	198	0
K052862	FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)	Bryan Keropian Dds	2005-12-30	80	0
K053131	WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-228	Wako Chemicals USA, Inc.	2005-12-30	52	0
K052115	FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (	First Check Diagnostics, LLC	2005-12-29	147	1
K052972	DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3	GE Healthcare	2005-12-29	66	3
K053308	ABX MICROS CRP 200, OPTION IM	Horiba Abx	2005-12-29	31	1
K053266	MYOTRAC INFINITI	Thought Technology , Ltd.	2005-12-29	36	0
K052725	PROTECTOR NEEDLE SHEATH PROP	Certol International, LLC	2005-12-28	90	0
K052425	ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGE	Zimmer, Inc.	2005-12-28	117	0
K053503	VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)	Vax-D Medical Technologies USA, L.C.	2005-12-28	12	0
K052735	ALLOCRAFT DBM	Lifecell Corp.	2005-12-28	89	2
K052706	A-200 POWERED WHEELCHAIR	Otto Bock Healthcare LP	2005-12-27	90	0
K051903	FETALGARD LITE-NIBP, MODEL FGL-NIBP	Analogic Corporation	2005-12-27	167	0
K053276	IST PEDICLE SCREW SYSTEM	Innovative Spinal Technologies, Inc.	2005-12-27	34	0
K051290	TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (U	Procter & Gamble Co.	2005-12-27	223	0
K052787	ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), A	Exactech, Inc.	2005-12-27	85	0
K052942	21.3INCH MONOCHROME LCD MONITOR	Nec-Mitsubishi Electric Visual Systems Corp.	2005-12-27	68	0
K052265	SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL	Smith & Nephew, Inc.	2005-12-27	130	42
K053447	ARTHROCARE PERC-D SPINEWAND	Arthrocare Corp.	2005-12-27	18	0
K053414	MENTOR NOVASILK MESH	Mentor Corp.	2005-12-27	20	0
K052875	PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES	Summit Manufacturing, LLC	2005-12-27	76	0
K052385	TANGORS POLYAXIAL SYSTEM	Ulrich GmbH & Co. KG	2005-12-27	119	0
K052917	STRYKER COMPARTMENTAL KNEE SYSTEM	Howmedica Osteonics Corp.	2005-12-27	71	7
K050365	BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202	Hyphen Biomed	2005-12-27	316	1
K052848	SPECTRA HAIR REMOVAL LASER	Spectragenics, Inc.	2005-12-27	81	0
K053482	SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW	Sutura, Inc.	2005-12-27	13	0
K052678	AQ-830 SLIM BODY, BODY FAT MONITOR	Limax Electronics Co., Ltd.	2005-12-27	90	0
K052587	3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF	J. Morita USA, Inc.	2005-12-27	98	0
K053008	E-Z-EM ENDOSCOPIC CO2 REGULATOR	E-Z-Em, Inc.	2005-12-27	62	0
K053104	DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CA	Dade Behring, Inc.	2005-12-23	49	0
K052751	VENTLINK SYSTEM	Mediserve Information Systems, Inc.	2005-12-23	84	0
K053140	AMBU MARK IV RESUSCITATOR	Ambu A/S	2005-12-23	44	0
K052826	QMS QUINIDINE. QMS QUINIDINE CALIBRATORS	Seradyn, Inc.	2005-12-23	79	0
K052283	HEART STG SYSTEM AND SOFTWARE	Stethographics, Inc.	2005-12-23	123	0
K052885	ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17	Nobel Biocare USA, LLC	2005-12-23	71	0
K052867	VITROS CHEMISTRY PRODUCTS DTIBC REAGENT	Ortho-Clinical Diagnostics, Inc.	2005-12-23	73	0
K052819	VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND	Ortho-Clinical Diagnostics, Inc.	2005-12-23	80	0
K052562	ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF	Interacoustics AS	2005-12-23	95	0
K052471	HDC SPIDER SCREW	Hdc S.R.L.	2005-12-23	106	0
K051030	COAG-A-MATE MTX III	bioMerieux, Inc.	2005-12-23	245	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