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 848 of 3530

510(k) clearances, page 848 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130091	Pulmosal	Pharmacaribe LLC	CAF	Class II	2013-03-13
K124053	Navigator Delivery System (Navigator Ds)	Carticept Medical, Inc.	FRN	Class II	2013-03-13
K123897	K Series CPAP Systems	Curative Medical, Inc.	BZD	Class II	2013-03-13
K123522	Optima Mr450w	GE Healthcare (GE Medical Systems, LLC)	LNH	Class II	2013-03-13
K123416	Insignia with Itero	Ormco Corp.	DYW	Class II	2013-03-13
K123370	Ez Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion Aortic Perfusion Cannula	Edwards Lifesciences LLC	DWF	Class II	2013-03-13
K123169	Oralid	Forward Science, LLC	NXV	Class II	2013-03-13
K122602	Nobelprocera Ti Abutment Camlog Platforms	Nobel Biocare AB	NHA	Class II	2013-03-13
K122412	Visiofocus	Tecnimed S.r.l.	FLL	Class II	2013-03-13
K121156	Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies	Phadia AB	DHB	Class II	2013-03-13
K120089	Biogenesis Implant System	Biogenesis Co., Ltd.	DZE	Class II	2013-03-13
K130153	Hearstart Mrx with Airway Confimration Assist	Philips North America LLC	MKJ	Class III	2013-03-12
K123939	S4 Spinal System	Aesculap Inc	NKB	Class II	2013-03-12
K123862	Zimmer Nexel Total Elbow	Zimmer GmbH	JDC	Class II	2013-03-12
K123584	Syngo, CT Bone Reading	Siemens Medical Solutions USA, Inc.	JAK	Class II	2013-03-12
K123345	Digital Flat Panel X-Ray Detector / 1012Wca	Rayence Co., Ltd.	MQB	Class II	2013-03-12
K122981	Rayscan a-Expert 3D	Ray Co., Ltd.	OAS	Class II	2013-03-12
K122634	Iodofoam Iodophor Foam Dressing	Progressive Wound Care Technologies, LLC	FRO	Unclassified	2013-03-12
K122113	Memory Metal Staples, Easyclip	Stryker Corp.	JDR	Class II	2013-03-12
K122071	Getinge 400Hc-E / Series Steam Sterilizer	Getinge Sourcing, LLC	FLE	Class II	2013-03-12
K121864	Perkinelmer 226 Sample Collection Devices	Revvity Health Sciences, Inc.	PJC	Class II	2013-03-12
K121685	Soprocare	Sopro	NBL	Class II	2013-03-12
K130395	Stereos Workstation	EOS imaging	LLZ	Class II	2013-03-11
K130113	Piccolo Lactate Test System	Abaxis Inc	KHP	Class I	2013-03-11
K123875	Aap Radius Set 2.5	AAP Implantate AG	HRS	Class II	2013-03-11
K123815	Surface Applicator Set with Leipzig-Style Cone	Varian Medical Systems, Inc.	JAQ	Class II	2013-03-11
K123702	Silex Sacroiliac Joint Fusion System	Xtant Medical Holdings, Inc.	OUR	Class II	2013-03-11
K123614	Solarys Ventilator Aerosol Delivery System (as)	Trudell Medical Intl.	CAF	Class II	2013-03-11
K123487	Gso Gs1 Cannulated Screw System	Gold Standard Orthopaedics, LLC	MNH	Class II	2013-03-11
K123073	Digital Automatic Blood Pressure Monitor Bpm03 Series Model Md03x0	Grandway Technology (Shenzhen) Limited	DXN	Class II	2013-03-11
K122736	Dx-D Imaging Package	AGFA Healthcare Corp.	MQB	Class II	2013-03-11
K121904	Gynecology Sterilization Tray	Smith & Nephew, Inc.	KCT	Class II	2013-03-11
K121825	Cs-Mag II	Biomagnetik-Park GmbH	DPS	Class II	2013-03-11
K113164	Discovery Tmax Manual Wheelchair	Otto Bock Healthcare LP	IOR	Class I	2013-03-11
K130128	Trinity Acetabular System	Corin Limited	LZO	Class II	2013-03-08
K130034	Uni-Picc	Health Line International Corporation	LJS	Class II	2013-03-08
K123998	Quidel Molecular Direct C. Difficile Assay	Ortho-Clinical Diagnostics, Inc.	OZN	Class II	2013-03-08
K123955	Quantstudio Dx Real-Time PCR Instrument	Life Technologies Corporation	OOI	Class II	2013-03-08
K123776	Polaris 100/200	Drager Medical B.V.	FTD	Class II	2013-03-08
K123725	Fastpack Control Kit	Qualigen Inc	JJY	Class I	2013-03-08
K123228	Inbody 770, Inbody 570, Inbody S10, Inbody H20/inbody H20(b)	Biospace Inc.	MNW	Class II	2013-03-08
K123212	Ethicon Endo-Surgery Enseal G2 Cordless Tissue Sealers	Ethicon Endo-Surgery Inc	PDG	Class II	2013-03-08
K123151	Endosee Model 8000 U-Scope	Endosee Corp	HIH	Class II	2013-03-08
K122806	Image Works Panoura	Mic International	MUH	Class II	2013-03-08
K122469	Asahi Ptca Guide Wire Asahi Sion 180Cmj Asahi Ptca Guide Wire Asahi Sion 300Cmj	Asahi Intecc Co., Ltd.	DQX	Class II	2013-03-08
K122468	Asahi Ptca Guide Wire Asahi Sion Blue 180Cm Asahi Ptca Guide Wire Asahi Sion Blue 3300Cm Asahi Ptca Guide Wire Asahi Sio	Asahi Intecc Co., Ltd.	DQX	Class II	2013-03-08
K122306	Synovis Collagen Matrix (Tbd)	SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)	DXZ	Class II	2013-03-08
K122189	Quidel Molecular Rsv + Hmpv Assay	Ortho-Clinical Diagnostics, Inc.	OEM	Class II	2013-03-08
K121285	Oravan Osa	New Jersey Snoring Solutions	LRK	Class II	2013-03-08
K113636	Blood Glucose Monitoring System (Glucose Oxidase)	Philosys, Inc.	CGA	Class II	2013-03-08