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 1711 of 3531

510(k) clearances, page 1711 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991024	Bone Bullet Suture Anchor	Linvatec Corporation	HWC	Class II	1999-11-16
K993344	P10 Special	North American Alloys, Inc.	EJH	Class II	1999-11-15
K993012	Minimed Com-Station, Hardware-7301; Software-7311	Medtronic, Inc.	LZG	Class II	1999-11-15
K992838	Adhere Conditioner, Adhere Primer, Adhere Lc Adhesive, Adhere Dc Adhere Dc Activator, Adhere Cylanate	Biomat Sciences, Inc.	KLE	Class II	1999-11-15
K993665	Legend Crf Fluoro and Rad System	GE Healthcare	KPR	Class II	1999-11-12
K993632	Fasttake Compact Blood Glucose Monitoring System	Selfcare, Inc.	CGA	Class II	1999-11-12
K993620	Impresario	Del Mar Medical Systems, LLC	DQK	Class II	1999-11-12
K993558	Ezflow Max, Model 1007	Piper Medical Products	CAF	Class II	1999-11-12
K993321	R&d Hgb/glc Whole Blood Control	R & D Systems, Inc.	GGM	Class II	1999-11-12
K993254	Immulite 2000 Folic Acid, Model L2kf02, L2kf06	Siemens Healthcare Diagnostics Inc.	CGN	Class II	1999-11-12
K993250	The Aptus (Automated) Application of the Gliadin Igg Elisa Test System.	Zeus Scientific LLC	MST	Class II	1999-11-12
K993162	Wako Transferrin, Transferrin Calibrator	FUJIFILM Healthcare Americas Corporation	DDG	Class II	1999-11-12
K993109	Varelisa Recombi Ana Profile	Pharmacia & Upjohn Company LLC	LJM	Class II	1999-11-12
K993108	Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96	Pharmacia & Upjohn Company LLC	LJM	Class II	1999-11-12
K993087	Autostat II Anti-Gliadin Igg Elisa	Cogent Diagnotics, Ltd.	MST	Class II	1999-11-12
K993086	Autostat II Anti-Gliadin Iga Elisa	Cogent Diagnotics, Ltd.	MST	Class II	1999-11-12
K992921	Primus Liquid Control for Ghb/alc Level I and Level II	Trinity Biotech (Primus Corporation dba Trinity Biotech)	LCP	Class II	1999-11-12
K992863	Lead Stylet,models 6505,6506,6507,6508	Boston Scientific Corporation	DRB	Class II	1999-11-12
K992791	Brahms Diagnostica Dynotest Anti-Tpo	Brahms Diagnostica, LLC	JZO	Class II	1999-11-12
K992790	Brahms Diagnostica Dynotest Anti-Tg	Brahms Diagnostica, LLC	JZO	Class II	1999-11-12
K992777	Constellation Catheters, Model 8039	Boston Scientific Corporation	MTD	Class II	1999-11-12
K992770	Qualitrol Immunology Control, Level 1, 2 and 3	Seracare Technology	JJY	Class I	1999-11-12
K991315	Microalbustix Reagent Strips (OTC)	Bayer Corp.	JIR	Class I	1999-11-12
K990927	Sigma 3400 Monoplace Hyperbaric Chamber	Perry Baromedical Corporation	CBF	Class II	1999-11-12
K993624	Site-Rite 3 Ultrasound System	Dymax Corp	IYO	Class II	1999-11-10
K993583	Zurich Titanium Ossicular Replacement System	Stryker Corp.	ETA	Class II	1999-11-10
K993488	Light-Core	Bisco Inc	EBF	Class II	1999-11-10
K993458	Powdered Latex Examination Gloves (Protein Label Claim)	Sri Johani Sdn. Bhd.	LYY	Class I	1999-11-10
K993434	Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-a	BIOTRONIK AG	DXY	Class III	1999-11-10
K993385	Autojet 2 (Non-Fixed Needle Type)	Owen Mumford USA, Inc.	KZH	Class II	1999-11-10
K993234	Micromedics S&t Partial Ossicular Replacement Prosthesis	Micromedics, Inc.	ETB	Class II	1999-11-10
K993167	Millennium Infant Ventilator	Sechrist Industries Inc	CBK	Class II	1999-11-10
K993021	Metrx System	Surgical Navigation Technologies, Inc.	HRX	Class II	1999-11-10
K992969	Respironics Total Face Mask	Respironics, Inc.	BZD	Class II	1999-11-10
K992906	Components for Cardiovascular Procedure Kit	Olson Medical Sales, Inc.	DTL	Class II	1999-11-10
K992857	Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070	Rocky Mountain Research, Inc.	DTW	Class II	1999-11-10
K992833	Vacuum Assist Stabilizer	Cardio Thoracic Systems	MWS	Class I	1999-11-10
K992733	Akron Atp9 Traction Machine	Huntleigh Technology, Inc.	ITH	Class II	1999-11-10
K992731	E.cam Computer	Siemens Medical Solutions USA, Inc.	KPS	Class II	1999-11-10
K992722	Primeaire	Thayer Medical Corportation	CAF	Class II	1999-11-10
K992713	Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101	Medtronic Functional Diagnostics A/S	FFX	Class II	1999-11-10
K992505	Teratech, Model 2000 Imaging Imaging	Teratech Corp.	IYO	Class II	1999-11-10
K992234	The Taper-Fit Total Hip System	Corin USA	JDG	Class II	1999-11-10
K991561	Roadrunner, Pep Therapy Device	Dhd Healthcare Corp.	BWF	Class II	1999-11-10
K991320	Medcomp Duo-Flow II Catheter with Lubricious Heparin	Medical Components, Inc.	MPB	Class II	1999-11-10
K991052	Fs 1000 Knee System	Renaissance Instruments, LLC	JWH	Class II	1999-11-10
K993712	Biliblanket Plus High Output Phototherapy System	GE Healthcare	FMZ	Class II	1999-11-09
K993469	Wako L-Type Ua F Test	FUJIFILM Healthcare Americas Corporation	KNK	Class I	1999-11-09
K993466	Wako L-Type Triglyceride Test	FUJIFILM Healthcare Americas Corporation	CDT	Class I	1999-11-09
K993453	Meniscus Arrow, Models 531110, 531113, 531116	Bionx Implants, Inc.	MAI	Class II	1999-11-09