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 2026-10-26, 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 664 of 3530

510(k) clearances, page 664 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K160272	Endophys Pressure Sensing Sheath Kit	Endophys, Inc.	DYB	Class II	2016-03-04
K160257	PROTEK Duo 31 Fr. Veno-Venous Cannula Set	Cardiacassist, Inc.	DWF	Class II	2016-03-04
K160237	Cefaly	Cefaly Technology	PCC	Class II	2016-03-04
K153513	Insufflator 50L FM134	Novanta Medical GmbH	HIF	Class II	2016-03-04
K153346	syngo Application Software VD11	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2016-03-04
K153212	Sheathes Ultrasound Probe Covers	Sheathing Technologies Inc	ITX	Class II	2016-03-04
K152957	MultiCross Catheter	Roxwood Medical, Inc.	DQY	Class II	2016-03-04
K152897	Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory	Integra LifeSciences Corporation	JXG	Class II	2016-03-04
K152861	Aquasil Ultra + Smart Wetting Impression Material	Dentply International, Inc.	ELW	Class II	2016-03-04
K152547	DNAP Electrode	AD-Tech Medical Instrument Corp.	GZL	Class II	2016-03-04
K152482	Propeller Sensor Model 2014-R	Reciprocal Labs Corporation	CAF	Class II	2016-03-04
K152421	IS4000 Stapler 30 Instrument and Stapler 30 Reloads	Intuitive Surgical, Inc.	NAY	Class II	2016-03-04
K152402	IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)	Securus,Inc	FLL	Class II	2016-03-04
K152249	ASAHI Corsair Armet	Asahi Intecc Co., Ltd.	DQY	Class II	2016-03-04
K152238	Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5	Sun Capsule, Inc.	LEJ	Class II	2016-03-04
K151847	SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens	Smart Performer Corp., Ltd.	LPL	Class II	2016-03-04
K151789	LOCATOR F-Tx Attachment System	Zest Anchors LLC	NHA	Class II	2016-03-04
K151597	Family of Steam Sterilizers B 28 series	Cefla S.C.	FLE	Class II	2016-03-04
K151590	Straumann RN Gold Abutment for Bridge	Straumann USA, LLC	NHA	Class II	2016-03-04
K151136	Harmonic Hook	Ethicon Endo-Surgery Inc	LFL	Unclassified	2016-03-04
DEN140017	Sensimed Triggerfish	Sensimed SA	PLZ	Class II	2016-03-04
K160347	Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21	Qingdao Hisense Medical Equipment Co.,Ltd.	PGY	Class II	2016-03-03
K160276	Acl Top (Acl Top 700, Acl Top 700 Cts, Acl Top 700 Las, Acl Top 500 Cts, Acl Top 300 Cts)	Instrumentation Laboratory Co.	GKP	Class II	2016-03-03
K153746	Dunamis Force DFX Tensile Tape	Dunamis, LLC	GAT	Class II	2016-03-03
K153448	Passport Series Patient Monitors (Including Passport 8, Passport 12)	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2016-03-03
K153299	Tenex Health TX System	Tenex Health	LFL	Unclassified	2016-03-03
K153253	GC Reline II	GC America Inc.	EBI	Class II	2016-03-03
K153206	Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1	FUJIFILM Healthcare Americas Corporation	FDS	Class II	2016-03-03
K152602	Olea Sphere V3.0	Olea Medical	LLZ	Class II	2016-03-03
K152061	IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JZO	Class II	2016-03-03
K151745	FULL CARE Disposable PVC Nelaton Catheter	Shaoxing Fuqing Health Products Co., Ltd.	EZD	Class II	2016-03-03
K151123	Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film	Pac-Dent International, Inc.	PEM	Class II	2016-03-03
K160241	Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215	Olympus Medical Systems Corp.	KNS	Class II	2016-03-02
K160020	Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System	CAPTIVA SPINE, Inc.	MNH	Class II	2016-03-02
K153527	PicoWay Laser System	Syneron Candela Corporation	GEX	Class II	2016-03-02
K153438	PERIMETER C (Titanium) Spinal System	Medtronic Sofamor Danek USA Inc	ODP	Class II	2016-03-02
K153245	Baha 5 Super Power Sound Processor	Cochlear Americas	LXB	Class II	2016-03-02
K153044	Sentimag System, Sentimark Magnetic Marker Systerm	Endomagnetics Ltd	PBY	Class II	2016-03-02
K152558	Leksell Stereotactic System, Injection/ Aspiration Needle Kit	Elekta Instrument AB	HAW	Class II	2016-03-02
K152280	BioPhotas Celluma3	Biophotas, Inc.	ILY	Class II	2016-03-02
K152050	Pencylcap	B.Braun Melsungen AG	FMI	Class II	2016-03-02
K151708	RECON system - Compression Screws	Normed Medizin-Technik GmbH	HWC	Class II	2016-03-02
K151700	BEAUTIFIL II Gingiva	Shofu Dental Corp.	EBF	Class II	2016-03-02
K151024	Finger Type Pulse Oximeter	Taidoc Technology Corporation	DQA	Class II	2016-03-02
K160230	VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm	Medtronic, Inc.	GCJ	Class II	2016-03-01
K160185	Wrist 3	Aspect Imaging Ltd	LNH	Class II	2016-03-01
K153460	Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)	Avinger, Inc.	MCW	Class II	2016-03-01
K153237	OrthAlign Plus System	OrthAlign, Inc.	OLO	Class II	2016-03-01
K152748	Braun Thermoscan PRO 6000 Ear Thermometer	Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)	FLL	Class II	2016-03-01
K152719	Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves	Xinfu Medical Products Co., Ltd.	LYZ	Class I	2016-03-01