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 2228 of 3531

510(k) clearances, page 2228 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K936218	See Monsters Sunglasses	Doppler, Inc.	HQY	Class I	1994-02-22
K936217	Eyeglass Frames	Ocean Optical Co., Inc.	HQZ	Class I	1994-02-22
K936149	Elite Collection	Omega Group, Inc.	HQZ	Class I	1994-02-22
K936146	Spectacle Frames	Franel Optical	HQY	Class I	1994-02-22
K936124	Howmedica Monotube T-Connector	Howmedica Corp.	JEC	Class II	1994-02-22
K936104	R & D Batteries	R & D Batteries, Inc.	HLJ	Class II	1994-02-22
K936045	Ace Unilateral Fixator II	Ace Orthopedic Manufacturing Co.	JEC	Class II	1994-02-22
K936033	Sunglasses	Tung Fang Mei Shieh Co., Ltd.	HQY	Class I	1994-02-22
K936018	Replacement Batteries Part No. 5098,5135, 5097	R & D Batteries, Inc.	HLJ	Class II	1994-02-22
K936004	Optical Frames	Europa Continental, Inc.	HQZ	Class I	1994-02-22
K935988	R&d Batteries # 5615, 5234, 5097	R & D Batteries, Inc.	HLI	Class II	1994-02-22
K935969	Spectacle Frames	Tae Kyung Optical Co., Inc.	HQY	Class I	1994-02-22
K935968	Spectacle Frames	Sae Biang Optical Co.	HQZ	Class I	1994-02-22
K935903	Splashmaster Prescription Eyewear	Cabot Safety Corp.	HQY	Class I	1994-02-22
K935858	Mill-Rose Percutaneous Procedural Kit	Mill-Rose Laboratory	LRO	Class II	1994-02-22
K935764	Non-Prescription Sunglasses	Airess, Inc.	HQY	Class I	1994-02-22
K935740	Irrigation Tray	Cush Medical Products	LRO	Class II	1994-02-22
K935654	Scimed 10 Fr. Lg. Lumen Triguide Plus(tm) Guid Cath	Scimed Life Systems, Inc.	DQO	Class II	1994-02-22
K935584	Mednext Bur	Mednext, Inc.	EQJ	Class I	1994-02-22
K935538	Bauer Temno Coaxial Needle	Bauer Medical, Inc.	GDF	Class I	1994-02-22
K935114	Sunglasses (Non-Prescription)	Promising Enterprise CO, Ltd.	HQY	Class I	1994-02-22
K935105	Reflex Esp with Finger Switches	Richard-Allan Medical	GEI	Class II	1994-02-22
K934894	Cultureswab Transport System	Difco Laboratories, Inc.	JTW	Class I	1994-02-22
K934698	Howmedica Mono-Tube Single Pin Clamp	Howmedica Corp.	JEC	Class II	1994-02-22
K934663	60 Degree Fundus Camera, Cf-60Ud	Canon Medical Components U.S.A., Inc.	HKI	Class II	1994-02-22
K934603	Surgical Saw Blades	American Medical Specialties, Inc.	GFA	Class I	1994-02-22
K934466	Spectacle Frames	Airess, Inc.	HQZ	Class I	1994-02-22
K934459	Med-Genesis Patient Laser Eye Shield	Med-Genesis, Inc.	IWS	Class I	1994-02-22
K934440	Pca Acetabular Insert II, Additional Sizes, Styles	Howmedica Corp.	JDL	Class III	1994-02-22
K934176	Surgical Accessories Looped Wire	Surgical Accessories, Inc.	JDQ	Class II	1994-02-22
K934148	True/flex Clavicle Rods	Applied Osteo Systems, Inc.	HSB	Class II	1994-02-22
K934127	Sarns Low Jetting Aortic Arch Cannula	3M Health Care, Sarns	DWF	Class II	1994-02-22
K933819	Sunglasses	California Bazar	HQY	Class I	1994-02-22
K933633	Low-Vision Reading Aid, Helpmate 2020, Vision-Aide, Lv Helpmate	Gracefully Yours, Inc.	HJG	Class I	1994-02-22
K933619	Pd-Pak	General Medical Mfg. Co.	MLW	Class II	1994-02-22
K933361	Acumed Radius Rod	Acu Med, Inc.	HSB	Class II	1994-02-22
K933353	Irrigation and Aspiration Device for Laparoscopic and Open Surgical Procedures	Utah Pioneer Medical, Inc.	GCJ	Class II	1994-02-22
K933345	Nobles-Lai Endoscopic/laparoscopic	Nobles-Lai Engineering, Inc.	GCJ	Class II	1994-02-22
K933137	Acu-Suture Kit	Acuderm, Inc.	LRO	Class II	1994-02-22
K933079	Electrocautery System Model 1980	PMT Corp.	HQP	Class II	1994-02-22
K933027	The Modular Nail	Smith & Nephew Richards, Inc.	HSB	Class II	1994-02-22
K932854	Ez Grip Disposable Electrodes	Advanced Adhesives	GZJ	Class II	1994-02-22
K932853	Pin Holders, Transfixing Pins, Ol Wires, Half Pins	Applied Osteo Systems, Inc.	JEL	Class II	1994-02-22
K932654	Electrosurgial Instruments	MEDLINE INDUSTRIES, LP - Northfield	GEI	Class II	1994-02-22
K932538	Cabot Medical Irrigation Fluid Warmer Sets	Cabot Medical Corp.	LHC	Class I	1994-02-22
K932512	Multi-Port Manifold	Baxter Healthcare Corporation	FMG	Class II	1994-02-22
K932483	Sundash	Sun Ind., Inc.	LEJ	Class II	1994-02-22
K931734	Intermedics Orthopedics Drill Bits	Intermedics Orthopedics	HWE	Class I	1994-02-22
K931729	i.v. Start Kit	Carapace, Inc.	FOZ	Class II	1994-02-22
K931675	Medline's Examin, Operating Room/surg Lights/lamps	MEDLINE INDUSTRIES, LP - Northfield	FTD	Class II	1994-02-22