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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 869 of 3530

510(k) clearances, page 869 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123182	Osom Influenza A&b Test Model 190	Sekisui Diagnostics, LLC	GNX	Class I	2012-11-05
K122512	Cs2 Hip System	Consensus Orthopedics, Inc.	LPH	Class II	2012-11-05
K122425	Vapr P50 Suction Electrode Vapr S90 Suction Electrode Vapr P50 Suction Electrode with Handcontrols Vaprs90 Suction Elect	DePuy Mitek, Inc.	GEI	Class II	2012-11-05
K122058	Flexiport Ecocuff	Welch Allyn Inc	DXQ	Class II	2012-11-05
K121858	The Ablation System	Halt Medical, Inc.	HFG	Class II	2012-11-05
K121786	Dymaxeon Spine System	B2b Spine Pty, Ltd.	NKB	Class II	2012-11-05
K121692	Minime 2 Nasal Mask	SleepNet Corporation	BZD	Class II	2012-11-05
K121562	Altis Single Incision Cling System	MEDLINE INDUSTRIES, LP - Northfield	PAH	Class II	2012-11-05
K121509	Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert	Tgm Medical, Inc.	KWY	Class II	2012-11-05
K121434	Software Syngo Mr D13a for the Magnetom Systems Aera/skyra/avanto/verio	Siemens Medi Cal Solutions, Inc.	LNH	Class II	2012-11-05
K120280	Relieva Seeker Balloon Sinuplasty System	Acclarent Inc	LRC	Class I	2012-11-05
K123267	Surfflash(r) Plus Safety i.v. Catheter	Kofu Factory of Terumo Corp.	FOZ	Class II	2012-11-02
K123185	Dc-8/Dc-8 Pro/dc-8, Cv/dc-8, Exp/dc-8S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2012-11-02
K123179	Ajust Helical Adjustable Single-Incision Sling	C.R. Bard Inc	PAH	Class II	2012-11-02
K123021	Bioplex 2200 Ebv Igm Kit	Bio-Rad Laboratories Inc.	LJN	Class I	2012-11-02
K122938	Forum Forum Archive Forum Archive & Viewer Forum Assist Match	Carl Zeiss Meditec Inc	NFJ	Class II	2012-11-02
K122646	Ds Breast 16Ch I/t 1.5T Ds Breast 16Ch I/t 3.0T	Invivo Corporation	MOS	Class II	2012-11-02
K122636	Revelation Porous Coated Hip Stem, Size 8	Encore Medical, LP	LPH	Class II	2012-11-02
K122436	Composix L/p Mesh with Echo Ps Positioning System Ventralight St Mesh with Echo Ps Positioning System	C.R. Bard Inc	FTL	Class II	2012-11-02
K122401	Tango M2 Blood Pressure Monitor	Suntech Medical, Inc.	DXN	Class II	2012-11-02
K122389	Trusculpt	Cutera Inc	PBX	Class II	2012-11-02
K122367	Bard Ptv Dilatation Catheter	C.R. Bard Inc	OMZ	Class II	2012-11-02
K122192	Nc Temporary Abutment, Cad-Temp, Pmma Rc Temporary Abutment, Cad-Temp, Pmma Rn Temporary Abutment, Cad-Temp, Pmma Wn Tem	Straumann USA, LLC	NHA	Class II	2012-11-02
K121878	Cardioblate Cryoflex Surgical Ablation Probes	Medtronic, Inc.	OCL	Class II	2012-11-02
K121539	Xpert Gbs Lb Genexpert Dx Systems (Gx-I, Gx-IV) Genexpert Dx Systems (Gx-Xvi) Genexpert Infinity-48 System (900-Xxxx)	Cepheid	NJR	Class I	2012-11-02
K121213	Vitreaadvanced	Canon Medical Informatics, Inc.	LLZ	Class II	2012-11-02
K121200	Flightplan for Liver	GE Healthcare	LLZ	Class II	2012-11-02
K121026	Flo-Guard Breathing Filter	Intersurgical Ltd.	CAH	Class II	2012-11-02
K120909	Ec 2.7 Endoscopic Cutter	Medtronic Navigation, Inc	GEI	Class II	2012-11-02
K120642	Resuscitaire with Autobreath	Draeger Medical Systems, Inc.	FMT	Class II	2012-11-02
K120555	Latex Male Condom (Smooth Surface) Latex Male Condom (Textured Surface)	Medical-Latex (Dua) Sdn. Bhd	HIS	Class II	2012-11-02
K112735	Tamarin Blue Ptca Rx Dilatation Catheter	Natec Medical Ltd	LOX	Class II	2012-11-02
K112396	Iui Catheters	Kitazato Medical Co., Ltd.	MQF	Class II	2012-11-02
K122637	Lite Decompression System- Light Cable Model 48089999	Howmedica Osteonics Corp	FST	Class II	2012-11-01
K122496	Audx Pro Otoacoustic Emissions Measurement System	Bio-Logic Systems Corp.	EWO	Class II	2012-11-01
K122350	Tap Pap Nasal Pillow Mask	Airway Management Inc.	BZD	Class II	2012-11-01
K122294	Pressurized Infusion Pump	Mui Scientific	FFX	Class II	2012-11-01
K122115	Collagen Dental Wound Dressings	Collagen Matrix, Inc	KGN	Unclassified	2012-11-01
K121793	An Evo 1, Cs Evo 1, Contact Mini, Apollon	Audifon-USA, Inc.	LXB	Class II	2012-11-01
K121560	Levant, Homeglide	Thyssenkrupp Accessibility B.V.	ILK	Class II	2012-11-01
K121315	Stryker Cmf Medpor Customized Implant	Howmedica Osteonics Corp	FWP	Class II	2012-11-01
K120350	Extended Life Battery	AED Battery Exchange, LLC	MKJ	Class III	2012-11-01
K112700	Frontier Sadl Interbody Fusion Device	Frontier Medical Devices, Inc.	OVD	Class II	2012-11-01
K122876	Multiflex Tinnitus Technology	Starkey Laboratories, Inc.	KLW	Class II	2012-10-31
K122478	Modified Trevo Retriever	Concentric Medical, Inc.	NRY	Class II	2012-10-31
K122434	Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel	Medtronic Xomed, Inc.	NHB	Class II	2012-10-31
K122395	Depuy Agility Lp Total Ankle Prosthesis	Depuy Orthopaedics Inc.	HSN	Class II	2012-10-31
K122314	Quatro Link Knotless Anchor with Inserter, 2.9Mm-Peek Only	Cayenne Medical Inc.	MBI	Class II	2012-10-31
K122313	Stryker Universal Smartlock Hybrid Mmf System	Stryker Corp.	JEY	Class II	2012-10-31
K122163	Certex Spinal Implant System	Xtant Medical Holdings, Inc.	MNI	Class II	2012-10-31