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 1275 of 3531

510(k) clearances, page 1275 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060134	Apollo Ir Heat Lamp System	Apollo Physical Therapy Products International	ILY	Class II	2006-03-21
K060121	Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip Applications	Biomet Manufacturing Corp	HAW	Class II	2006-03-21
K053582	Inquiry Afocus II Diagnostic Catheter	Irvine Biomedical. Inc.	DRF	Class II	2006-03-21
K051953	Everstick A&o	Stick Tech Ltd.	DYW	Class II	2006-03-21
K051719	A.b. Dental Devices	A.B. Dental Devices Ltd	DZE	Class II	2006-03-21
K060468	Vectorvision Hip	Brainlab, Inc.	HAW	Class II	2006-03-20
K060459	Quadrostar 980	Asclepion Laser Technologies GmbH	GEX	Class II	2006-03-20
K060457	Quadrostar 532	Asclepion Laser Technologies GmbH	GEX	Class II	2006-03-20
K060455	Multistar	Asclepion Laser Technologies GmbH	GEX	Class II	2006-03-20
K060406	Norian Srs Fast Set Putty	Synthes (USA) Products LLC	MQV	Class II	2006-03-20
K060156	Straight Plate with Angular Stability & Screw System	I.T.S. Implantat-Technologie-Systeme GmbH	HRS	Class II	2006-03-20
K053510	Ir Wireless Foot Switch	Linemaster Switch Corp.	GEI	Class II	2006-03-20
K053047	Fraxel Sr Laser System	Reliant Technologies, Inc.	GEX	Class II	2006-03-20
K052844	Kavs - Catheter, Models 1107100 & 1107060	Richter & Rothe AG	MJN	Class II	2006-03-20
K060631	Biograph 64 and Biograph 40	Siemens Medical Solutions USA, Inc.	KPS	Class II	2006-03-17
K060531	Quickie Rhythm & Groove Series Power Wheelchairs W/quickie Delphi Controls	Sunrise Medical, Inc.	ITI	Class II	2006-03-17
K060514	Stryker Plating System	Howmedica Osteonics Corp	HRS	Class II	2006-03-17
K060475	Evis Exera Ultrasonic Bronchofibervideoscope, Olympus Model Bf Type Uc160f-Ol8	Olympus Medical Systems Corp.	ODB	Class II	2006-03-17
K060424	Panoramic, Model 200Ma	Optos PLC.	MYC	Class II	2006-03-17
K060286	Tigecycline Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	2006-03-17
K060267	Virtual Implant Placement (Vip) Dental Implant Surgery Planning Software	Implant Logic Systems, Ltd.	LLZ	Class II	2006-03-17
K060218	Bd Phoenix Automated Microbiology System - Erythromycin-0.0625-8 Ug/ml, and Quinupristin/dalfopristin-0.25-4 Ug/ml	Becton Dickinson & Co	LON	Class II	2006-03-17
K060173	Acon 30 Second Reliable Digital Thermometer, Acon Digital Thermometer Probe Covers	Acon Laboratories, Inc.	FLL	Class II	2006-03-17
K053587	Ortho Development Ceramic Femoral Heads with Pres-Fit Stems	Ortho Development Corp.	LZO	Class II	2006-03-17
K053345	Pro-Line CT Power Injectable Cvc, Models Ctlines5s, Ctline6d	Medcomp	LJS	Class II	2006-03-17
K052785	OTC TENS for Low Back Pain Relief, Model Wl-2405 and Wl-2406	Well-Life Healthcare Limited	NUH	Class II	2006-03-17
K051684	Eyeport Vision Training System	Exercise Your Eyes, Inc.	NXR	Class I	2006-03-17
K051542	Triosyn T40 Antimicrobial Wound Dressing	Triosyn Corp.	FRO	Unclassified	2006-03-17
K051093	Osteopore Pcl Scaffold	Osteopore, Inc.	GXP	Class II	2006-03-17
K043593	Spine-Fix Biomimetic Bone Cement	Teknimed SAS	NDN	Class II	2006-03-17
K060637	Denfil Flow	Vericom Co., Ltd.	EBF	Class II	2006-03-16
K060582	Invacare Topaz Bariatric Manual Wheelchair	Invacare GmbH	IOR	Class I	2006-03-16
K060484	Erbe Vio Esu, Model Vio 300 D	Erbe USA Inc	GEI	Class II	2006-03-16
K060440	Codonics Horizon Xl Digital Direct Long Film Imager; Codonics Horizon Xl-X Long Film Imager	Codonics, Inc.	LMC	Class II	2006-03-16
K060285	Bonegen - Tr	Bio-Lok Intl., Inc.	LYC	Class II	2006-03-16
K060216	Energist Ultra Vpl Intense Pulse Light System	Energist Limited	GEX	Class II	2006-03-16
K060137	Kodak Eclipse Image Processing Software	Eastman Kodak Company	MQB	Class II	2006-03-16
K060132	Spinal USA Cement Restrictor System	Spinal USA	JDK	Class II	2006-03-16
K060127	Hemicap Patello-Femoral Resurfacing Prosthesis	Arthrosurface, Inc.	KRR	Class II	2006-03-16
K060125	Sonic Palpometer	Palpometer Systems, Inc.	IKE	Class I	2006-03-16
K060110	Celltracks Analyzer II	Immunicon Corp.	NQI	Class II	2006-03-16
K053607	Breas Vivo 40 System	Breas Medical AB	MNT	Class II	2006-03-16
K053560	Modified Endosheath System for Vsi Flexible Cystoscope	Cogentix Medical, Inc.	FAJ	Class II	2006-03-16
K053536	Durom Acetabular Component and Metasul Ldh Large Diameter Heads	Zimmer GmbH	KWA	Class III	2006-03-16
K053495	Equipment Slush Drape	Advance Medical Designs Inc	KKX	Class II	2006-03-16
K053477	Masimo Set Rad 57 Cm and M Pulse Co-Oximeters	Masimo Corporation	DQA	Class II	2006-03-16
K053431	Attain Select II 6248Del Delivery Catheter System	Medtronic Ireland	DQY	Class II	2006-03-16
K053339	Allofix Anchor	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	GAT	Class II	2006-03-16
K053075	N Antisera to Human Transferrin	Siemens Healthcare Diagnostics Inc.	DDG	Class II	2006-03-16
K053074	N Antisera to Human Ceruloplasmin	Siemens Healthcare Diagnostics Inc.	DDB	Class II	2006-03-16