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

2012 — Predicate Candidate Screening

3,135 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

114 daysmedian FDA review time

293 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K122111	RESPIRONICS SIMPLYCLEAR DEVICE	Respironics, Inc.	2012-12-31	167	0
K122481	LIPIVIEW OCULAR SURFACE INTERFEROMETER	Tearscience, Inc.	2012-12-31	139	0
K122474	LANSINOH POWERED ELECTRIC BREAST PUMP	Lansinoh Laboratories Saglik Gerecleri Tasarim San	2012-12-28	136	0
K121397	OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTR	SEKISUI Diagnostics, LLC	2012-12-28	233	0
K123167	DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM	Medos International SARL	2012-12-28	80	0
K123357	ONQ RTS	Oncology Systems, Inc.	2012-12-28	58	0
K121007	NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF	Delta Med Srl	2012-12-28	269	0
K122764	RAPID STRAND RX	Medi-Physics, Inc.	2012-12-28	109	0
K121297	ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR	Signature Orthopaedics Pty, Ltd.	2012-12-28	242	0
K121549	NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE	Siam Sempermed Corp., Ltd.	2012-12-27	216	0
K121661	EZ-ASSIST-FILL	Assist Fill, LLC	2012-12-27	205	0
K121693	A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)	Sapphire Medical Group, Inc.	2012-12-27	203	0
K122909	SYNGO SINGLE SOURCE DUAL ENGERY	Siemens Medical Systems, Inc.	2012-12-27	97	0
K120490	QUICK SAMPLER HOLDER	Nipro Medical Corporation	2012-12-27	314	0
K123683	NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MO	Aerocrine AB	2012-12-27	27	0
K123526	CLEARREAD +CONFIRM	Riverain Technologies	2012-12-27	42	0
K122039	KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+	Kettenbach GmbH & Co. KG	2012-12-27	169	0
K123663	LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL	Bio-Rad Laboratories	2012-12-27	29	0
K122749	PRESTIGE-MOBIE	Prestige Sporting Goods Co. , Ltd.	2012-12-27	111	0
K122784	NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM K	Bioness, Inc.	2012-12-27	107	0
K123091	VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T	Imris, Inc.	2012-12-27	86	0
K121653	INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS	Carl Zeiss Meditec, Inc.	2012-12-27	205	1
K123419	EVA SELECT DIGITAL DENTAL IMAGING SYSTEM	Afp Imaging Corp.	2012-12-27	51	0
K122134	FLEXLITE CAMERA	Spine View, Inc.	2012-12-27	162	0
K121710	XPERT CT/NG	Cepheid	2012-12-27	199	2
K123591	FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)	Medtronic Cryocath, LP	2012-12-27	36	0
K123017	STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324	Advanced Sterilization Products	2012-12-26	89	0
K123637	HAMILTON-C3	Hamilton Medical AG	2012-12-21	25	0
K122690	ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE	Arrow International, Inc.	2012-12-21	108	0
K122142	GLOOKO LOGBOOK CHARTS	Glooko, Inc.	2012-12-21	155	0
K123836	QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP	Surgical Specialties Corp. Dba Angiotech	2012-12-21	8	0
K122944	GEMORE TRUE SINE INTERFERENTIAL STIMULATOR	Gemore Technology Co, Ltd.	2012-12-21	88	0
K120822	STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARI	Institut Straumann AG	2012-12-21	277	0
K123260	DETACHATIP III	Conmed Corporation	2012-12-21	64	0
K123729	VERSARATE FLOW RATE CONTROLER	Emed Technologies Corporation	2012-12-21	16	0
K123341	ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX	Arthrex, Inc.	2012-12-21	51	0
K113010	FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULA	Famidoc Technology Co., Ltd.	2012-12-21	437	0
K123669	TRANSTEK WRIST BLOOD PRESSURE MONITOR	Zhongshan Transtek Electronics Co., Ltd.	2012-12-21	22	0
K123754	CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM	Philips Ultrasound, Inc.	2012-12-21	15	22
K123616	PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM	Sonoscape Company Limited	2012-12-21	28	0
K121077	NHANCER	Imds Operations B.V.	2012-12-21	256	0
K123172	KOGENT BIPOLAR FORCEPS	Katalyst Surgical, LLC	2012-12-21	73	0
K120948	PREXION 3D	The Yoshida Dental Mfg. Co., Ltd.	2012-12-21	267	0
K123611	E-CUBE 7	Alpinion Medical Systems Co., Ltd.	2012-12-21	30	0
K113023	STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER	Nxstage Medical, Inc.	2012-12-21	437	0
K123773	X-TRA BASE	Voco GmbH	2012-12-21	14	0
K121555	CENTURION VISION SYSTEM	Alcon Laboratories, Inc.	2012-12-21	210	4
K122106	SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-O	Veran Medical Technologies, Inc.	2012-12-21	157	13
K123191	XPERT FLU	Cepheid	2012-12-21	71	0
K122616	PANTHER OIS/R & V MODEL VERSION 2.0	Prowess, Inc.	2012-12-21	116	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