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 2405 of 3531

510(k) clearances, page 2405 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915368	Serena Wheelchair Cushions	A & C Medical Supply	KNN	Class I	1991-12-20
K915361	The Body Buggy	Innova Corp.	LYG	Class I	1991-12-20
K915242	Touch N Tone 1 Massager	Conair LLC.	IRO	Class I	1991-12-20
K915241	Sports Heat Wrap	Conair LLC.	IRT	Class II	1991-12-20
K915234	Hemagen Ena (Ss-A/ss-B) Kit (Eia Method)	Hemagen Diagnostics, Inc.	LLL	Class II	1991-12-20
K915058	Hemagen Ena Screening Kit (Eia Method)	Hemagen Diagnostics, Inc.	LLL	Class II	1991-12-20
K914985	Disposable Angiography Needle, Modification	E-Z-EM, Inc	DRC	Class II	1991-12-20
K914952	Model 1210 Omnipulse Holmium Laser System	Trimedyne, Inc.	GEX	Class II	1991-12-20
K914621	Iontophoresis Device, Modification	Iomed, Inc.	EGJ	Class II	1991-12-20
K914617	Catheter, Ureteral Dilator	Boston Scientific Corporation	EZN	Class II	1991-12-20
K914406	Pt II Distal Cement Spacer	Osteonics Corp.	JDI	Class II	1991-12-20
K914389	Alpha-2 Macroglobulin Test Rid Kit	The Binding Site	DEB	Class II	1991-12-20
K914330	Sos Bloodless Needle	E-Z-EM, Inc	DYB	Class II	1991-12-20
K914264	Transq 2	Iomed, Inc.	EGJ	Class II	1991-12-20
K913845	Philips Mammodiagnost Bc	Philips North America LLC	IZH	Class II	1991-12-20
K913672	Prealbumin Immunological Nl Test Kit	The Binding Site	JZJ	Class I	1991-12-20
K913668	Caeruloplasmin Immunological Nl Test Kit	The Binding Site	DDB	Class II	1991-12-20
K913363	Custom Tubing Packs	Kroy Medical, Inc.	DTL	Class II	1991-12-20
K913358	Midas System(tm) 5100 Physiolog Monit/record Syst	Ppg Industries, Inc.	DXG	Class II	1991-12-20
K913327	Contempro2 Home Health Care Regulator	Continental Products, Inc.	CAW	Class II	1991-12-20
K913231	S-Rom(tm) Total Lhip System W/ceramic Head	Joint Medical Products Corp.	JDI	Class II	1991-12-20
K913222	Optima	Olympic Controls Corp.	IZO	Class I	1991-12-20
K912854	Turbo	KCI USA, Inc.	IOQ	Class II	1991-12-20
K912712	Biomet Modular Total Hip Femoral Components	Zimmer GmbH	JDI	Class II	1991-12-20
K912418	Shikani Middle Meatal Antrostomy Vent Tube	Micromedics, Inc.	KAM	Class I	1991-12-20
K912417	Molar Distalizing Assembly	American Orthodontics	DYJ	Class I	1991-12-20
K911880	Zefon Adult Anesthesia Breathing Circuit	Bill Olson Corp.	CAI	Class I	1991-12-20
K911590	Immunowell Borrelia (Lyme)test	General Biometrics, Inc.	LSR	Class II	1991-12-20
K911116	Interson Endocavity Probe/kontron Ultrasound Syst	Interson Corp.	ITX	Class II	1991-12-20
K905073	Cardiovascular Repair Patch	Impra, Inc.	DXZ	Class II	1991-12-20
K901448	Veolar Ventilator	Hamilton Medical AG	CBK	Class II	1991-12-20
K915413	Cat-250B	Toshiba America Medical Systems, In.C	IZZ	Class II	1991-12-19
K915187	Cancellous Bone-L.p. and Cortical Bone Screw	Techmedica, Inc.	HWC	Class II	1991-12-19
K914974	Medtronic Model 9455 Teletrace III ECG Monit Syst	Medtronic, Inc.	DPS	Class II	1991-12-19
K914780	Talley Sd.500 Skin Pressure Evaluator	Talley Group Ltd.	IKE	Class I	1991-12-19
K914776	Oxford Pressure Monitor/talley Pressure Monitor	Talley Group Ltd.	JFC	Class I	1991-12-19
K914758	Mdt/shampaine Model 4900B Surgical Table	Mdt Corp., Inc.	GDC	Class I	1991-12-19
K914582	Kodak Ektascan 1120 Laser Printer	Eastman Kodak Company	LMC	Class II	1991-12-19
K914412	Mask, Surgical, Disposable	Industries for the Blind	FXX	Class II	1991-12-19
K914349	Provider Apm Infusion Pump	Abbott Medical	FRN	Class II	1991-12-19
K914297	K.d. Chin Implant	Implantech Associates Inc	FWP	Class II	1991-12-19
K914282	Nucleotome(r) II (Version2) Tissue Aspira/cutter	Surgical Dynamics Ltd	HRX	Class II	1991-12-19
K913810	Holmed Hand Held Instruments	Performance Surgical Instruments Corp.	GCJ	Class II	1991-12-19
K913612	Sequencer	Elekta Limited	IYE	Class II	1991-12-19
K913606	Chrys Xx CO2 Surgical Laser System	Jamar Medical Systems	GEX	Class II	1991-12-19
K913145	Nucleotome Tissue Aspirator/cutter	Surgical Dynamics Ltd	HRX	Class II	1991-12-19
K912991	Wilde Auxiliaries	Wilde-USA, Inc.	EBI	Class II	1991-12-19
K912588	Automatic Digital Blood Pressure Meters, Models	Sein Electronics Co., Ltd.	DXN	Class II	1991-12-19
K911960	Branemark System-3.0Mm Fixture	Nobelpharma USA, Inc.	DZE	Class II	1991-12-19
K915371	Cocaine Metabolite Eia Test	Diagnostic Reagents, Inc.	DIO	Class II	1991-12-18