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 2026-10-29, 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 818 of 3530

510(k) clearances, page 818 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132216	Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution	Bausch & Lomb Incorporated	LPN	Class II	2013-09-09
K132073	Ep-Workmate, Ep-Nursemate, Ep-Nursemate with Physio Module	Abbott Medical	DQK	Class II	2013-09-09
K131138	Respire Pink Series - Herbst	Respire Medical	LRK	Class II	2013-09-09
K123630	Fresenius Liberty Cycler	Fresenius Medical Care North America, Design Cente	FKX	Class II	2013-09-09
K122102	Power Free Vinyl Examination Gloves	Wang Tong Xinghua Co., Ltd.	LYZ	Class I	2013-09-09
K132431	Thermage Cpt System	Solta Medical, Inc.	GEI	Class II	2013-09-06
K132324	Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System, Uniplate 2 Anterior Cervical Plate Syst	Medos International SARL	KWQ	Class II	2013-09-06
K132239	Comprehensive Reverse Shoulder Screws	Biomet Manufacturing Corp	PHX	Class II	2013-09-06
K132233	K-Pack II Needle - 27G X 3/4 Thin Wall	Terumo Europe N.V.	FMI	Class II	2013-09-06
K132136	Single Use Grounding Pad	Lccs Products Limited	GEI	Class II	2013-09-06
K131813	Quidel Molecular Rsv + Hmpv Assay	Ortho-Clinical Diagnostics, Inc.	OCC	Class II	2013-09-06
K131681	Eyeseecam Vhit	Interacoustics a/S	GWN	Class II	2013-09-06
K131658	Gore Seamguard Reinforcement	W. L. Gore & Associates, Inc.	OXC	Class II	2013-09-06
K131442	Firecr Dentalimaging System	3Disc Americas	MUH	Class II	2013-09-06
K131389	Jusha-C31 Medical Display	Nanjing Jusha Display Technology Co., Ltd	LLZ	Class II	2013-09-06
K131357	Peak Z	Ultradent Products Inc.	KLE	Class II	2013-09-06
K131037	Liaison Xl Hcg	Diasorin Inc.	DHA	Class II	2013-09-06
K130893	Xperct Rel. 3	Philips Medical Systems Nederland B.V.	OWB	Class II	2013-09-06
K130409	Alivecor Heart Monitor	AliveCor	DPS	Class II	2013-09-06
K130349	Freemie Breast Collection System	Dao Health	HGX	Class II	2013-09-06
K130341	Strawberry, Strawberry & Cream	Laser Lipo Limited	OLI	Class II	2013-09-06
K130010	Prosigna(tm) Breast Cancer Prognostic Gene Signature Assay	Nanostring Technologies	NYI	Class II	2013-09-06
K122235	Rusch Tracflex Plus Tracheostomy Tube Set	Teleflexmedical, Inc.	JOH	Class II	2013-09-06
K121844	Powder Free Natural Rubber Latex Examination Gloves	Worldmed Manufacturing Sdn. Bhd.	LYY	Class I	2013-09-06
K121033	Virtuoso System for Ihc Ki-67 (30-9)	Ventana Medical Systems Inc	NOT	Class II	2013-09-06
K132492	Liaison 25 Total-D	Diasorin Inc.	MRG	Class II	2013-09-05
K132348	Tephaflex Braided Suture	Tepha, Inc.	NWJ	Class II	2013-09-05
K131764	Acumed Wrist Spanning Plate	Acumed LLC	HRS	Class II	2013-09-05
K131701	Z5mlb, Z5mlc	Z-Systems AG	DZE	Class II	2013-09-05
K131452	Pressurewire; Certus, Certus 300, Aeris, Aeris 300	St. Jude Medical Systems AB	DXO	Class II	2013-09-05
K131311	Arix Foot System	Jeil Medical Corporation	HRS	Class II	2013-09-05
K123944	Kostec Medical Grade Ldc Monitors	Kostec Co., Ltd.	LLZ	Class II	2013-09-05
K123811	Stitchkit	ORIGAMI SURGICAL Inc.	NBY	Class II	2013-09-05
K123723	Synthes Matrixneuro Cranial Plating System	Synthes GmbH	GWO	Class II	2013-09-05
K132610	5Mp Grayscale Lcd Display	Shenzhen Beacon Display Technology Co., Ltd.	LLZ	Class II	2013-09-04
K132045	Advantagesim Md with CT Atlas-Based Contouring and Re-Planning Options	GE Hungary Kft	KPQ	Class II	2013-09-04
K131980	Sequoia Pedicle Screw System Including Speedlink II Transverse Connector System	Zimmer Spine, Inc.	NKB	Class II	2013-09-04
K131615	Polaris Spinal System	Biomet Spine (Aka Ebi, LLC)	OSH	Class II	2013-09-04
K131148	The Cvc Wand Safety Introducer with Valved Peelable Sheath	Access Scientific, Inc.	DYB	Class II	2013-09-04
K131064	Biospace	Biospace Inc.	DXN	Class II	2013-09-04
K131044	Sensicardiac Mobi Diagnostic Heart Murmur Application	Diacoustic Medical Devices (Pty), Ltd.	DQD	Class II	2013-09-04
K121924	Integra Interspinous Process System	Seaspine, Inc.	PEK	Class II	2013-09-04
K132455	U-Motion II Ps+ Cup	United Orthopedic Corp.	LZO	Class II	2013-09-03
K132366	Spinal Intervertebral Body Fixation Orthosis	Accel Spine	KWQ	Class II	2013-09-03
K131540	Interfuse L Intervertebral Body Fusion Device	Vertebral Technologies, Inc.	MAX	Class II	2013-09-03
K131296	Varilift-L Interbody Fusion Device	Wenzel Spine	MAX	Class II	2013-09-03
K131242	Ardis Interbody System	Zimmer Spine, Inc.	MAX	Class II	2013-09-03
K130028	Resurfx 1565Nm Laser Module	Lumenis Ltd	ONG	Class II	2013-09-03
K123907	Prelude Pf Femoral Components (Mim Cocrmo), Prelude Pf Femoral Components (Cast Cocrmo), Prelude Pf Patella Components,	Biomet Manufacturing Corp	KRR	Class II	2013-09-03
K132374	Baylis Medical RF Perforation Probe V2.0	Baylis Medical Co., Inc.	GEI	Class II	2013-08-30