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 2026-11-02, 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 1060 of 3531

510(k) clearances, page 1060 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K091638	Dorado Wide Intervertebral Body Cage, Models: Im2010-Im2031	SPINEFRONTIER, Inc. dba LESspine Innovations	MAX	Class II	2009-09-14
K091488	Footprint Medical Peripherally Inserted Central Catheter, Model S1pic1.9-C	Footprint Medical Inc.	LJS	Class II	2009-09-14
K091187	Grace Dynamic Torp	Grace Medical, Inc.	ETA	Class II	2009-09-14
K091135	Rutter Supra Stomal Stents	Boston Medical Products, Inc.	FWN	Class II	2009-09-14
K090174	Tsi; Eri	Oco Biomedical	DZE	Class II	2009-09-14
K083567	Gii Spinal Fixation System, Gii-Ti-Poly Axial Screw	Co-Ligne AG	MNH	Class II	2009-09-14
K092612	D-Stat Rad-Band, Rad-Band, Models 3501, 3505	Vascular Solutions LLC	QSX	Unclassified	2009-09-11
K092553	Tru Flu, Model 751230	Meridian Bioscience Inc	PSZ	Class II	2009-09-11
K092497	Smith & Nephew Pigalileo Screw Targeting System, Version 1.1	Smith & Nephew, Inc.	OLO	Class II	2009-09-11
K092372	Heartrail III Guiding Catheter	Terumo Corp.	DQO	Class II	2009-09-11
K091799	Cable Ready Cable Grip System Cable Button	Zimmer GmbH	HTN	Class II	2009-09-11
K091508	Zimmer Continuum Acetabular System, Zimmer Trilogy It Acetabular System	Zimmer GmbH	LPH	Class II	2009-09-11
K091321	Osteoselect Demineralized Bone Matrix Putty	Xtant Medical Holdings, Inc.	MQV	Class II	2009-09-11
K091223	Valleylab Suction Coagulator, Model E3305	Medtronic, Inc.	GEI	Class II	2009-09-11
K091171	D3 Ultra Duet Dfa Respiratory Virus Identification Kit	Ortho-Clinical Diagnostics, Inc.	OMG	Class II	2009-09-11
K090911	Ist Snoring Appliance	Dental Crafters	LQZ	Class II	2009-09-11
K083783	Vf Liquigel	Coapt Systems, Inc.	MIX	Class II	2009-09-11
K083679	Uroval Brs System, Model Brs01; Telesis, Model Promo1	Uroval	IKN	Class II	2009-09-11
K083536	Densichek Plus	bioMerieux, Inc.	LON	Class II	2009-09-11
K082811	Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers	URIT Medical Electronic Co., Ltd.	JIO	Class II	2009-09-11
DEN090004	Ova1 Test	Vermillion	ONX	Class II	2009-09-11
DEN080006	Ulthera System, Model 8850-0001	Merz North America, Inc.	OHV	Class II	2009-09-11
K092635	Alcatel-Lucent Teleheath Manager	Alcatel-Lucent Canada, Inc.	DRG	Class II	2009-09-10
K091943	Powerheart AED G3, Model 9390E, Powerheart AED G3 Automatic, Model 9390A	ZOLL Medical Corporation	MKJ	Class III	2009-09-10
K091852	Bisque Zirconia Blanks, Model R610191, R610210, R610211, R610205	Refractron Technologies Corp.	EIH	Class II	2009-09-10
K091843	Comfort Twin Nasal Mask	Respironics Inc., Sleep & Home Respiratory Group	BZD	Class II	2009-09-10
K091808	Sensei Robotic Catheter System, Model 02057	Hansen Medical, Inc.	DXX	Class II	2009-09-10
K091614	Osteomed Foot Plating System	Osteomed	HRS	Class II	2009-09-10
K090175	Unity Beta Plla System	Bonutti Research, Inc.	HWC	Class II	2009-09-10
K092441	Modification to: Conformis Iuni Unicondylar Knee Repair System	ConforMIS, Inc.	HSX	Class II	2009-09-09
K092237	Nsm-S15 System	Neusoft Medical Systems Co., Ltd.	LNH	Class II	2009-09-09
K091937	Office-Spec Disposable Side-Opening Speculum	Obp Corporation	HIB	Class II	2009-09-09
K091544	S-Test Lactate Dehydrogenase (Ld), Model Rc 0017	Alfa Wassermann	CFJ	Class II	2009-09-09
K090104	Liaison 25 Oh Vitamin D Total Calibration Verifiers, Model: 310603	Diasorin Inc.	JJX	Class I	2009-09-09
K082841	Spinal Foraminoscope	Blazejewski Medi-Tech GmbH	HRX	Class II	2009-09-09
K091921	Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft, Reinforcing, Mini Aneurysm Clip	Cerenovus, Inc.	HCH	Class II	2009-09-08
K091619	Anglefix T Locking Plate, Models Af-001 (Plate), St-1 (Locking Screw)	Anglefix	KTT	Class II	2009-09-08
K091562	Doctor Smile a-810 and B-980 Lasers	Lambda Scientific SpA	GEX	Class II	2009-09-08
K092645	Fdi Glucose Control Levels 1, 2 and 3	Fujirebio Diagnostics, Inc.	JJX	Class I	2009-09-05
K092576	Gem Heart One/one+	Gem-Med S.L.	DPS	Class II	2009-09-04
K092552	Clo-Surplus P.a.d.	Scion Cardio-Vascular, Inc.	QSY	Unclassified	2009-09-04
K092455	Modification to: Polarcath Peripheral Dilatation System	Boston Scientific Corporation	LIT	Class II	2009-09-04
K092430	1 Ml Fixed Needle, 3 Ml Luer Lock, 5 Ml Luer Lock, 10 Ml Luer Lock, 20 Ml Luerl Lock Safety Syringes	Inviro Medical Devices, Inc.	MEG	Class II	2009-09-04
K092413	Invirosnap 50 and 100 Unit Insulin Safety Syringes	Inviro Medical Devices, Inc.	MEG	Class II	2009-09-04
K092396	Spectranetics Quick Cross Extreme Support Catheters	Spectranetics Corp.	DQY	Class II	2009-09-04
K092375	Modification to Si Joint Fusion System	SI-Bone, Inc.	OUR	Class II	2009-09-04
K092365	Inreach System, Model Aas00161-02	Medtronic, Inc.	JAK	Class II	2009-09-04
K091991	Easy Ra D Bil Reagent Model 10212, Easy Ra Glu-H Reagent Model 10200	Medica Corp.	CIG	Class II	2009-09-04
K091652	Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy Drugs	Hartalega Sdn Bhd	LZA	Class I	2009-09-04
K091588	Ucp Home Drug Screening Tests	Ucp Biosciences, Inc.	DKZ	Class II	2009-09-04