510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1319 of 3531

510(k) clearances, page 1319 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051524	Lock-It Plus Regional Anesthesia Catheter Securement Device, Model 100/399/216	Abbott Medical	BSO	Class II	2005-07-07
K051490	Ge Oec Everview 7500	GE Healthcare	OXO	Class II	2005-07-07
K051372	Powder Free Nitrile Examination Gloves with Peppermint Scented (Blue Color)	Platinum Glove Industries Sdn. Bhd.	LZA	Class I	2005-07-07
K051358	Nature-Cryl Hi Plus	GC America Inc.	EBI	Class II	2005-07-07
K051323	Merete Twistcut Snap-Off Bone Screw	Merete GmbH	HWC	Class II	2005-07-07
K051098	Periarticular Locking Plates and Screws, Model 2358 Series	Zimmer GmbH	HWC	Class II	2005-07-07
K050966	Pivot Bipolar Femoral Head	Ortho Development Corp.	KWY	Class II	2005-07-07
K050855	Palamed G	Kulzer GmbH	LOD	Class II	2005-07-07
K050854	Palacos Lv+g	Kulzer GmbH	LOD	Class II	2005-07-07
K050832	Fluency Plus Tracheobronchial Stent Graft	Bard Peripheral Vascular Inc	JCT	Class II	2005-07-07
K050793	Landlex Model S400x	Cycling and Health Tech. Industry R&D Center	INI	Class II	2005-07-07
K050690	Connexus	IsoTis OrthoBiologics, Inc.	MQV	Class II	2005-07-07
K050507	Smartech, Model Holi I	Cycling and Health Tech. Industry R&D Center	INI	Class II	2005-07-07
K050449	Quantum Vertebral Body Replacement	Quantum Orthopedics, Inc.	MQP	Class II	2005-07-07
K050444	Nobelreplace Adapter, Model 32412	Nobel Biocare Uas, Inc.	NHA	Class II	2005-07-07
K042472	Bd Directigen Ez Flu a + B	Becton Dickinson & Co	PSZ	Class II	2005-07-07
K051498	Disposable Powdered Vinyl Exam Glove Yellow Color	Ever Global Enterprise Corporation	LYZ	Class I	2005-07-06
K051486	Norwood Abbey Centurion Ses Epikeratome	Norwood Abbey, Ltd.	HNO	Class I	2005-07-06
K051268	Radiance Acne System with Cleartouch Light Unit	Radiancy, Ltd.	GEX	Class II	2005-07-06
K051185	Elecsys Ca 19-9 Calcheck	Roche Diagnostics GmbH	JJY	Class I	2005-07-06
K051110	1,25-Dihydroxy Vitamin D Eia	Immunodiagnostic Systems Ltd.	MRG	Class II	2005-07-06
K051024	Expedium Spine System	DePuy Spine, Inc.	NKB	Class II	2005-07-06
K050231	Elecsys Ca 19-9 Immunoassay, Elecsys Ca 19-9 Calset	Roche Diagnostics GmbH	JIT	Class II	2005-07-06
K043238	Compressor Nebulizer, Model EMG Nba02-Xxx Series	EMG Technology Co., Ltd.	CAF	Class II	2005-07-06
K042725	Quest Diagnostics Haircheck-Dt (Opiates)	Quest Diagnostics, Inc.	DJG	Class II	2005-07-06
K042522	Jaundice Meter, Model Jm 103	Draeger Medical Infant Care, Inc.	MQM	Class I	2005-07-06
K051517	Elecsys Precicontrol Anemia	Roche Diagnostics GmbH	JJY	Class I	2005-07-05
K051266	Bd Phoenix Automated Microbiology System - Linezolid (Strep) 0.25 - 16Ug/ml	Becton Dickinson & Co	LON	Class II	2005-07-05
K051191	Dcl Microalbumin Assay, Model 252-20	Sekisui Diagnostics P.E.I. Inc.	DCF	Class II	2005-07-05
K050841	Fraxel Sr Laser System	Reliant Technologies, Inc.	GEX	Class II	2005-07-05
K051541	Gf-Ue160-Al5 Ultrasound Endoscope	OLYMPUS Corporation of the Americas	FDF	Class II	2005-07-01
K051474	Symbios Disposable Infusion Pump Kit	Symbios Medical Products, LLC	MEB	Class II	2005-07-01
K051423	Mick Hdr Interstitial Implant Accessories	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2005-07-01
K051418	Direct Digitizer Regius Model 370	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2005-07-01
K051255	Lumiphase-R	Opusmed, Inc.	GEX	Class II	2005-07-01
K051184	55 Sv, Multifocal and Toric (Ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear	United Contact Lens Inc	LPL	Class II	2005-07-01
K051136	Smith & Nephew Cds System	Smith & Nephew, Inc.	JAA	Class II	2005-07-01
K051106	The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 and Mp90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	DXN	Class II	2005-07-01
K050940	Pmp4 Medical Web Center	Card Guard Scientific Survival, Ltd.	DXH	Class II	2005-07-01
K050653	Transear Bone Conduction Hearing Aid	United Hearing Systems, Inc.	LXB	Class II	2005-07-01
K050018	Teslaoxysat, Model Efoxysate	Mammendorfer Institute for Physics & Medicine GmbH	DQA	Class II	2005-07-01
K043353	Omega Excel/xp Laser System	Advanced Medical Technologies AG	NHN	Class II	2005-07-01
K042875	Navigator	Nomos Corp.	IYE	Class II	2005-07-01
K042791	Instant-X, Models 1713 & 128	Ann Arbor Digital Devices	MQB	Class II	2005-07-01
K041653	Compel 1-Ply Surgical Gowns; Compel Isolation Gowns	Standard Textile Co., Inc.	FYA	Class II	2005-07-01
K041008	Eye-Cept Rewetting Drops	Optics Laboratory, Inc.	LPN	Class II	2005-07-01
K051557	Trigen Retrograde Femoral, Supracondylar and Tibial Nails	Smith & Nephew, Inc.	JDS	Class II	2005-06-30
K051491	Trabecular Metal Primary Hip Prosthesis	Zimmer GmbH	LPH	Class II	2005-06-30
K051417	6 Fr Fl Powerhohn and Powerline Catheter	C.R. Bard Inc	LJS	Class II	2005-06-30
K051399	Wavelight Auriga	Wavelight Laser Technologie AG	GEX	Class II	2005-06-30