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 2026-10-26, 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 2735 of 3530

510(k) clearances, page 2735 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881421	Dideco-Shiley Feed Tube Support Arms and Hook	Shiley, Inc.	CAC	Class II	1988-05-04
K881343	Duraderm Butterfly	Sentry Medical Products, Inc.	GXY	Class II	1988-05-04
K881276	Hr-5000 Electrosurgical Device for New Indications	Ime Co., Ltd.	KCW	Class I	1988-05-04
K881183	Ventricular Bolt Pressure Monitoring Kit #110-4H	Camino Laboratories, Inc.	GWM	Class II	1988-05-04
K880881	Artus Disposable Sheaths/cutters	Acufex Microsurgical, Inc.	HSZ	Class I	1988-05-04
K880574	Modified Imipenem Susceptibility Powder	Merck, Sharp & Dohme	JTT	Class II	1988-05-04
K880524	Three Phase Diagnostic X-Ray Generator Micro-X 100	Fischer Imaging Corp.	IZO	Class I	1988-05-04
K880523	Three Phase, Diagnostic Generator Micro-X 75	Fischer Imaging Corp.	IZO	Class I	1988-05-04
K880522	Three Phase, Diagnostic X-Ray Generator Micro-X 80	Fischer Imaging Corp.	IZO	Class I	1988-05-04
K880521	Single Phase Diagnostic X-Ray Generator Fx-650	Fischer Imaging Corp.	IZO	Class I	1988-05-04
K880519	Single Phase Diag. X-Ray Generator Micro-X 650	Fischer Imaging Corp.	IZO	Class I	1988-05-04
K880088	Cadwell Excel	Cadwell Laboratories, Inc.	GWF	Class II	1988-05-04
K881744	Porges Ureteral Stent	Bivona Medical Technologies	FAD	Class II	1988-05-03
K881219	Automatic Perimeter, Ap-340	Kowa Pharmaceuticals America, Inc.	HPT	Class I	1988-05-03
K880908	Model Pc Argon Laser	Hgm, Inc.	GEX	Class II	1988-05-03
K880771	Medsurg 7 Fr. Dual Lumen Central Vein Cath System	Medsurg Industries, Inc.	DQR	Class II	1988-05-03
K880490	Blue Plastic Eye Shield	Eye Garter Company, Inc.	HOY	Class I	1988-05-03
K880347	Anesthesia/retrobulbar Needles	Myocure, Inc.	HMX	Class I	1988-05-03
K880346	Cannulas	Myocure, Inc.	HMX	Class I	1988-05-03
K880345	Cystotomes/knifes	Myocure, Inc.	HNY	Class I	1988-05-03
K875381	Ultrasound Diathermy Unit Ultrasound Heater	Ford Laboratories, Inc.	IMI	Class II	1988-05-03
K875030	Ocu-1	Rudolph Beaver, Inc.	HMX	Class I	1988-05-03
K874591	Illuminating Infusion Contact Lens for Eye Surgery	Vitreo Dynamics, Co.	HPX	Unclassified	1988-05-03
K874569	Suredrop Eyedrop Guide	Suredrop, Inc.	JYJ	Class I	1988-05-03
K881348	Verify(r) Reference Plasma	bioMerieux, Inc.	GGN	Class II	1988-05-02
K881161	Tech-Cal(tm)/multiple	R & D Systems, Inc.	KSA	Class II	1988-05-02
K880865	Resubmitted Ergometer Exercise Bike Model Ft1300	Invacare GmbH	BXB	Class I	1988-05-02
K880776	7 Fr. Triple Lumen Central Vein Catheteri. System	Medsurg Industries, Inc.	DQR	Class II	1988-05-02
K880699	Endomed Cv405	Henley Intl.	IPF	Class II	1988-05-02
K880661	Fiberoptic Catheter	Optimed Technologies, Inc.	DQO	Class II	1988-05-02
K880616	Minos Automatic Cell Counter	Abx, Inc.	GKZ	Class II	1988-05-02
K880542	Dentalvision Tv System	Dentsply Intl.	EKJ	Class I	1988-05-02
K880531	Mammographic X-Ray System Athena	Fischer Imaging Corp.	IZH	Class II	1988-05-02
K880485	Xenex Dental Roulette	G & A Industries, Inc.	EFW	Class I	1988-05-02
K874738	10 and 12 French Vessel Dilators	Impra, Inc.	DRE	Class II	1988-05-02
K874558	Sl Series, Sl 15, 18, 20 & 25	Philips North America LLC	IYE	Class II	1988-05-02
K874363	Acuson S228 and S328 Transducers for Abdom. Appli.	Acuson Computed Sonography	IYO	Class II	1988-05-02
K873012	Infant Cannula	Gresco International, Inc.	DQR	Class II	1988-05-02
K881614	Modified Ohmeda PEEP Valve (for Gms Absorber)	GE Healthcare	BYE	Class II	1988-04-29
K881516	Compresaid	R. Evans Corp.	FZF	Class I	1988-04-29
K881499	Surgilase Yag 100 for Gynecology Use	Surgilase, Inc.	LLO	Class II	1988-04-29
K881487	Ophthalmic Cannula	Surgical Instrument, Inc.	HMX	Class I	1988-04-29
K881398	Tourniquet	Barretta Products, Research and Development, Inc.	GAX	Class I	1988-04-29
K881396	Operating Room Towels -Sterile & Non-Sterile	A Plus International, Inc	KKX	Class II	1988-04-29
K881390	Needle Shield Needle Disposal Unit	Xenetics Biomedical, Inc.	FPA	Class II	1988-04-29
K881117	Resubmitting of Hjd Total Hip System	Richards Medical Co., Inc.	JDI	Class II	1988-04-29
K880961	Alcon Surgical Procedure Packs	Alcon Laboratories	LRO	Class II	1988-04-29
K880960	Ndyag Laser Tracheal Tube	Sheridan Catheter Corp.	BTR	Class II	1988-04-29
K880928	Marquette Medical, Inc. IV Extension Sets	Marquette Medical, Inc.	FPA	Class II	1988-04-29
K880838	Bassinet Stand with Dressing Tray	Serv-Queen, Inc.	FMS	Class II	1988-04-29