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 2231 of 3531

510(k) clearances, page 2231 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931994	Resectoscope Sheath	Olympus Corp.	HIH	Class II	1994-02-17
K931665	6.5 Mm Cancellous Bone Screw	Encore Orthopedics, Inc.	HWC	Class II	1994-02-17
K931484	Replacement Batter for Abbott Labs Lifecare 4100 S	Portable Power Systems, Inc.	BZD	Class II	1994-02-17
K931483	Replacement Batery for Ge Amx-4 Port. X-Ray Mach.	Portable Power Systems, Inc.	IZL	Class II	1994-02-17
K931348	Battery Pack #1005Nc	Portable Power Systems, Inc.	BTA	Class II	1994-02-17
K931168	X-20 Air Support Bed	American Life Support Technology, Inc.	INX	Class II	1994-02-17
K930780	Adv400 Toe Cpm	Advanced Kinetics, Inc.	BXB	Class I	1994-02-17
K930418	Crypto-Lex System	Trinity Laboratories, Inc.	GMD	Class II	1994-02-17
K930270	Patient Preoperative Prep Tray, Single Use	Professional Medical Products, Inc.	LRO	Class II	1994-02-17
K930113	Kirwan Irrigation/aspiration Handpiece	Kirwan Surgical Products, LLC	HMX	Class I	1994-02-17
K926070	Primodent Acrylic Teeth	I.T.C. Ent.	ELM	Class II	1994-02-17
K925304	Autoref Lensmeter Rl-10	Canon Medical Components U.S.A., Inc.	HKO	Class I	1994-02-17
K925261	Nutricare Enteral Feeding Tube	Entracare Corp.	KNT	Class II	1994-02-17
K925160	Arthro Fms 4	Orthoconcept, Inc.	HRX	Class II	1994-02-17
K924065	Mic Peg Tube	Medical Innovations, Inc.	KNT	Class II	1994-02-17
K922343	Tri-Tech Inc. Custom Sexual Assault Kit	Tri-Tech, Inc.	JKA	Class II	1994-02-17
K922248	Mallawany Atraumatic Tissue Forceps	Numed Technologies, Inc.	HET	Class II	1994-02-17
K940111	Aurium 224	Argen Precious Metals, Inc.	EJT	Class II	1994-02-16
K935954	Optical Frame Collection No. 2	Frontier Novelty, Inc.	HQZ	Class I	1994-02-16
K935919	Sunglasses	Ja-Ru, Inc.	HQG	Class I	1994-02-16
K935918	Spectacle Frame	Kenmark Optical, LLC	HQZ	Class I	1994-02-16
K935798	Multiple -Spectacle Frames/sunglasses	Tae Kyung Optical Co., Inc.	HQZ	Class I	1994-02-16
K935729	Optical Frames And/or Sunglasses	Ivo Eyewear, Inc.	HQZ	Class I	1994-02-16
K935678	Sunglass Frame	Australian Optical Co., Inc.	HQY	Class I	1994-02-16
K935605	Spectacle Frames	Sovereign Eyewear, Inc.	HQZ	Class I	1994-02-16
K935226	i/v Pole	Optical Micro Systems, Inc.	KYG	Class I	1994-02-16
K934591	Clave Vial Access Spike	Abbott Medical	FMI	Class II	1994-02-16
K934528	2C Lens Fog Reduction & Cleaning Device	H & C Chemical, Inc.	GCJ	Class II	1994-02-16
K934320	Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion Aspiration	Mentor O & O, Inc.	HQR	Class II	1994-02-16
K933149	Instrument Detergent Concentrate	Nobelpharma USA, Inc.	FLG	Class I	1994-02-16
K932858	Ortholoc Advantim Tibial Base Component	Dow Corning Wright	JWH	Class II	1994-02-16
K932312	Fujinon Video Laparoscope -- Modified	FUJIFILM Healthcare Americas Corporation	FET	Class II	1994-02-16
K931338	16 Electrodes (Blade, Ball, Needle & Loop)	Apyx Medical Corporation	HGI	Class II	1994-02-16
K930659	Sunglasses	Kai Tai Optical Mfg. Co., Ltd.	HQY	Class I	1994-02-16
K930566	Ophthalmic Frames W/demo Lenses & Clip on Sunglass	E.B. Brown Opticians	HQZ	Class I	1994-02-16
K930123	Aspirating Endo Ocular Probe	Surgical Technologies, Inc.	EQH	Class I	1994-02-16
K925828	Modified Site Txr Systems	Site Microsurgical Systems, Inc.	HQC	Class II	1994-02-16
K925039	Safesnap Safety Syringe	U.S. Medical Instruments, Inc.	MEG	Class II	1994-02-16
K924380	Mdt/harvey Model 7000 & 8000 Chemiclave	Mdt Corp., Inc.	MLR	Class II	1994-02-16
K923452	Pmi Hip Femoral	Zimmer GmbH	LPH	Class II	1994-02-16
K921301	Taperloc Femoral Stem and Universal Acetabular Com	Zimmer GmbH	LPH	Class II	1994-02-16
K921277	Ranawat/burstein Total Hip System	Zimmer GmbH	LPH	Class II	1994-02-16
K921225	Integral Total Hip System	Zimmer GmbH	LZO	Class II	1994-02-16
K921224	Bimetric Total Hip System	Zimmer GmbH	LZO	Class II	1994-02-16
K921181	Mallory-Head Total Hip System	Zimmer GmbH	LZO	Class II	1994-02-16
K914715	Paralleling Guides	Implant Corp. of America	FZX	Class I	1994-02-16
K940193	Surgical Retractor Kit	Advanced Surgical, Inc.	GCJ	Class II	1994-02-15
K935848	Brady Medical Products Transorb Wound Dressing	Brady Medical Products Co.	NAE	Class I	1994-02-15
K935741	O.r. Basin Set Tray	Cush Medical Products	LRO	Class II	1994-02-15
K935705	Allevyn Island Wound Dressing	Smith & Nephew United, Inc.	NAE	Class I	1994-02-15