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 2182 of 3531

510(k) clearances, page 2182 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940628	Jihn Mei Optical Co.	Sunny Sunglasses	HQY	Class I	1994-07-12
K940627	Wenzhou Import and Export Corp	Sunny Sunglasses	HQY	Class I	1994-07-12
K940626	Clever Optical Industries Ltd	Sunny Sunglasses	HQY	Class I	1994-07-12
K940625	Chen Shueng Enterprise Co.	Sunny Sunglasses	HQY	Class I	1994-07-12
K940516	Auto Reff-30	Canon, Inc.	HKO	Class I	1994-07-12
K940488	Chen-Hersin Sunglasses	Chen Hersin Ent.	HQY	Class I	1994-07-12
K940429	Ortho Tech Cryologic System	Orthopedic Technology, Inc.	ILO	Class II	1994-07-12
K940207	Titanium Alloy Bone Screws	Aesculap Inc	HWC	Class II	1994-07-12
K936280	Galileo Arthroscopes	Galileo Electro-Optics Corp.	HRX	Class II	1994-07-12
K936143	Isocomforter	Isocomforter, Inc.	ILO	Class II	1994-07-12
K935167	Ogden Anchor (Modification)	American Medical Electronics, Inc.	JDR	Class II	1994-07-12
K933881	Depuy Motech Moss-Miami Spinal System	Depuy, Inc.	KWP	Class II	1994-07-12
K933196	The Signature Series, Ic II	Progressive Electrical Therapeutics	IPF	Class II	1994-07-12
K931468	Restore Hex Cylinder Endosseous System	Lifecore Biomedical LLC	DZE	Class II	1994-07-12
K930613	Hooking System	Alain Machtelinckx	LYG	Class I	1994-07-12
K926597	Laparoscope, Gynecologic (and Accessories)	Optimed Technologies, Inc.	HET	Class II	1994-07-12
K925596	Non-Prescription Sunglasses	European & Foreign Imports, Inc.	HQY	Class I	1994-07-12
K925355	Biosign(tm_ Rubella - Rubella Antibody Test	Princeton Biomedix	LFX	Class II	1994-07-12
K924112	Hydroxylapatite Coated Saber Tech Series I & Series II	Saber Technology, Inc.	DZE	Class II	1994-07-12
K942815	Hydroskin Wound Dressing	Hymedix Intl., Inc.	KMF	Class I	1994-07-11
K942798	Mpm Hydrogel	MPM Medical	MGQ	Unclassified	1994-07-11
K941239	Aesculap Neuroendoscope	Aesculap Inc	GWG	Class II	1994-07-11
K941058	Procath Pacing Threshold Cable	Professional Catheter Corp.	DSA	Class II	1994-07-11
K940409	M-K Hydrogel Dressing	Mason-Keller Corp.	MGQ	Unclassified	1994-07-11
K936099	Neurological Lead Accessories	Medtronic, Inc.	GZB	Class II	1994-07-11
K935189	E-Z Derm Biosynthetic Wound Dressing	Brennen Medical, Inc.	KGN	Unclassified	1994-07-11
K935146	Disposable Stethoscope Head Cover	Modern Medical Devices, Inc.	BZS	Class I	1994-07-11
K934051	Bio Sdp (Aka Saturn Sd, Glc-III Sd & Stat-Sd)	Skylark Device Co., Ltd.	GZJ	Class II	1994-07-11
K933284	As/3 Tm Network	Datex Division Instrumentarium Corp.	CCK	Class II	1994-07-11
K931560	Cardiac Catheterization Tray	Clinipad Corp.	DQO	Class II	1994-07-11
K942915	Electrosurgical Laparoscopic Instrument	Morgan Medical, Ltd.	GEI	Class II	1994-07-08
K942767	Alpha-Dent C-R(r) Hybrid Type II Composite Resin	Wallace A. Erickson & Co.	EBF	Class II	1994-07-08
K942758	Hypoallergen Non-Ster Powderfree Latex Pat Exam Glove	Aladan Corp.	LYY	Class I	1994-07-08
K942724	External Nasal Splint	Micromed Development Corp.	EPP	Class I	1994-07-08
K942678	Lifting Distention Balloon System	Origin Medsystems, Inc.	GCJ	Class II	1994-07-08
K942583	Peri-Strips Planar Configuration Staple Line Reinforcement	Bio-Vascular, Inc.	FTL	Class II	1994-07-08
K942521	Conserva Post System	Bull Frog Mfg. Co.	ELR	Class I	1994-07-08
K942418	Playtex Tampons Model 13794	Playtex, Inc.	HEB	Class II	1994-07-08
K942343	Laseaway Q-Switched Ruby Laser System	Polytec Pi, Inc.	GEX	Class II	1994-07-08
K942315	Navarre Percutaneous Access Set	Navarre Biomedical, Ltd.	KGZ	Class I	1994-07-08
K942313	Guardian Glove	Guardian Group, Inc.	LZC	Class I	1994-07-08
K942022	Face-It Shield	Onyx Medical LLC	LYU	Class I	1994-07-08
K941954	Non-Fogging Dental Mirror	Buffalo Dental Mfg Co Inc	EKJ	Class I	1994-07-08
K941910	Sunglasses	The Orvis Co., Inc.	HQY	Class I	1994-07-08
K940686	Electronic Thermometers	American Diagnostic Corp.	FLL	Class II	1994-07-08
K933906	Choledochoscope/endoscope Modification	FUJIFILM Healthcare Americas Corporation	FBN	Class II	1994-07-08
K933803	Disposable Tab Electrode	Cadwell Laboratories, Inc.	GXY	Class II	1994-07-08
K933318	Coherent Versapulse 2.1U /1.06U Compact Surgical Laser, Models a & B	Lumenis Ltd	GEX	Class II	1994-07-08
K931456	Surgical Drape and Gown Tray	Custom Medical Products, Ltd.	FYA	Class II	1994-07-08
K930071	Sargon Cylindro-Blade Implant	Sargon Ent., Inc.	DZE	Class II	1994-07-08