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 2401 of 3531

510(k) clearances, page 2401 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915875	Rionet Hearing Aid Hb-71K (K-Amp)	Authorized Hearing Systems, Inc.	ESD	Class I	1992-01-13
K915846	Biodex System 2 Autoprogram	Biodex Corp.	IKK	Class II	1992-01-13
K915671	B.a.s.e. Bellows Air Support Equipment	Progressive Medical Technology, Inc.	IOQ	Class II	1992-01-13
K915592	Pegasus Lateral Cardiac Positioner	Fischer Imaging Corp.	JAA	Class II	1992-01-13
K915262	Bantex Brand Wheelchairs	Bantex Corp.	IOR	Class I	1992-01-13
K915151	Auto Suture Modified Polymer Skin Graft Staple	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1992-01-13
K915108	Folding Wheelchair	Guardian Products Co., Inc.	IOR	Class I	1992-01-13
K915082	Opti-Lens(tm) Contact Lens Case	Ryder Intl. Corp.	LRX	Class II	1992-01-13
K914946	Cascade 480(Tm) Auto Coag Analyzer, Modification	Helena Laboratories, Corp.	GKP	Class II	1992-01-13
K914938	Micro Computer Controls, Model# Mcc-Mk-Rii-X	Invacare GmbH	ITI	Class II	1992-01-13
K914845	M170 Pneumatically Operated Oscillating Saw	Desutter Medical, Ltd.	HSZ	Class I	1992-01-13
K914737	Asl Model #104	Adaptive Switch Laboratories, Inc.	ITI	Class II	1992-01-13
K914676	Zimmer(r) Ceramic Femoral Heads 28Mm Diameter	Zimmer GmbH	LZO	Class II	1992-01-13
K914574	Exactech Ceramic Femoral Head Component	Exactech, Inc.	LZO	Class II	1992-01-13
K914343	Ti-Fit Femoral Component	Smith & Nephew Richards, Inc.	LWJ	Class II	1992-01-13
K913611	Cowboy	KCI USA, Inc.	JOW	Class II	1992-01-13
K913501	Tracheostomy Mask	B & F Medical Products, Inc.	BYG	Class I	1992-01-13
K913490	Phoenix Burr Hole Button, Burr 1	Phoenix Bioengineering, Inc.	GXR	Class II	1992-01-13
K913368	Models Mr700/mr720/mr730 Dual Servo Resp Humid Acc	Fisher & Paykel Electronics, Ltd.	BTT	Class II	1992-01-13
K912930	Interlocking Femoral Nailing System	Stryker Corp.	HSB	Class II	1992-01-13
K910976	Oregon Fixation Screw	Acu Med, Inc.	HWC	Class II	1992-01-13
K910173	Selectra and Tubing Sets	Medionics International, Inc.	FKX	Class II	1992-01-13
K904940	Olympus Infant Resectoscope and Accessories	Olympus Corp.	FJL	Class II	1992-01-13
K915142	Amcath Disposable Biopsy Forceps	Intl. Medical, Inc.	FCF	Class II	1992-01-10
K914978	Oxyguard	Stantex Pty, Ltd.	MNK	Class I	1992-01-10
K914897	Sonotone Behind the Ear Model St 54-0	Sonotone Intl., Inc.	ESD	Class I	1992-01-10
K914876	Opti-Amp	Intelligent Hearing Systems Corp.	GWL	Class II	1992-01-10
K914838	Propaq 102,104,106,102El,104el,&106el	Protocol Systems, Inc.	MHX	Class II	1992-01-10
K914709	Latex Patient Examination Gloves - Hypoallergenic	Klh Medical, Inc.	LYY	Class I	1992-01-10
K914563	Sterile Sugical Gown Pack	Assured Surgical Products, Inc.	FYA	Class II	1992-01-10
K914523	Cri Vessel Occlusin System/cri Occlusion Coil	Catheter Research C/O Burditt, Bowles & Radzius	DSS	Class II	1992-01-10
K914446	Uroview 2000, Modification	Oec-Diasonics, Inc.	JAA	Class II	1992-01-10
K914106	Pentax Ureterorenofiberscope, Model Fur-10P	Pentax Precision Instrument Corp.	FGB	Class II	1992-01-10
K914008	Pentax Cystofiberscope, Model Fcy-15P	Pentax Precision Instrument Corp.	FAJ	Class II	1992-01-10
K913933	Turnsoft Mattress	Turnsoft, Inc.	FNM	Class II	1992-01-10
K913386	Chemo-Port	Hdc Corp.	FMI	Class II	1992-01-10
K912803	Msi Sterile Back Surgical Gown Pack Hand Towel	Medical Sterilization, Inc.	FYA	Class II	1992-01-10
K905208	Morse Anesthesia	North American Instrument Corp.	FPA	Class II	1992-01-10
K915684	Rexton Rx34 with Horizon Programmable Option	Rexton, Inc.	ESD	Class I	1992-01-09
K915683	Rexton Rx12 with Horizon Programmable Option	Rexton, Inc.	ESD	Class I	1992-01-09
K915648	Biodex System 2 Autoprogram	Biodex Corp.	IKK	Class II	1992-01-09
K915629	Cushion, Whelchar and Flotation	Invacare GmbH	KNN	Class I	1992-01-09
K915519	Sonotone Behind the Ear Model St 53A	Sonotone Intl., Inc.	ESD	Class I	1992-01-09
K915518	Sonotone Behind the Ear Model St 49	Sonotone Intl., Inc.	ESD	Class I	1992-01-09
K915517	Sonotone Body Aid Model St 1000 Body Worn	Sonotone Intl., Inc.	ESD	Class I	1992-01-09
K915339	Gen-X 800/300	Swissray Finatech, Inc.	IZO	Class I	1992-01-09
K915319	Rionet Hearing Aid Hb-52As	Rion Co. Ltd. dba Rion Acoustic Device	ESD	Class I	1992-01-09
K915237	Philips PCR-Ace System	Philips North America LLC	LLZ	Class II	1992-01-09
K915232	Grundig Electronics Various Models	Perkins Mfg. Co.	IZI	Class II	1992-01-09
K915227	Gen-X 800/500	Swiss Ray Medical Systems	IZO	Class I	1992-01-09