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 2765 of 3530

510(k) clearances, page 2765 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874834	Argyle Cardioplegia Cannula	Sherwood Medical Co.	DWF	Class II	1988-01-19
K874796	Model EEG 4400 with Optional Accessories	Nihon Kohden America Inc	GWQ	Class II	1988-01-19
K874792	Model 5013 Transvenous Ventricular Pacing Lead	Medtronic, Inc.	DTB	Class III	1988-01-19
K874743	Pacing Leads Model 3262Vu/vb, 3362Vu/vb, 3380/3390	Pace Medical	DTB	Class III	1988-01-19
K874656	Automatic Ventilator Av2000	Life Support Products, Inc.	BTL	Class II	1988-01-19
K874651	Oticon Hearing Aid Model I52	Oticon, Inc.	ESD	Class I	1988-01-19
K874649	Cadd-Plus(tm) Model 5400 Ambulatory Infusion Pump	Pharmacia Deltec, Inc.	FRN	Class II	1988-01-19
K874618	Baxter Accuport(tm) Central Venous Catheter	Bentley Laboratories, Inc.	DQR	Class II	1988-01-19
K874597	Thermovent 600, 1200, T, 02	Abbott Medical	BYD	Class I	1988-01-19
K874581	Ivac(r) Dual Rate Adapter - Model 70090	Y	FPA	Class II	1988-01-19
K874579	Coeur Control Syringe	Coeur Laboratories, Inc.	FMF	Class II	1988-01-19
K874508	H-H External Ventricular Drainage Collection Bag	Holter-Hausner Intl.	JXG	Class II	1988-01-19
K874441	Bard Biopotential Amplifier	C.R. Bard Inc	DRR	Class II	1988-01-19
K874384	Audiotone Model a-90, Behind-the-Ear Hearing Aid	Audiotone, Inc.	ESD	Class I	1988-01-19
K874374	The Woog Oratest	Woog Intl.	EAZ	Class I	1988-01-19
K874369	Concha, Cavum, Canal, Concha-P Hearing Aid	Altamonte Hearing Clinic	ESD	Class I	1988-01-19
K874321	Solco Silicone Resuscitator	Kahn-Tact U.S.A., Inc.	BTM	Class II	1988-01-19
K874275	Optec Supplementary Kit	Pentron Corp.	EBF	Class II	1988-01-19
K874188	Coulter Immunoprep Leukocyte/q-Prep Immuno Wrk Sta	Coulter Electronics, Inc.	GKM	Class I	1988-01-19
K874135	Condom (Prophylactic)	Pactec, Inc.	HIS	Class II	1988-01-19
K874132	Miniox IV Portable Pulse Oximeter	Catalyst Research Corp.	DQA	Class II	1988-01-19
K873985	Fluoro Cover	Condor Medical	JAA	Class II	1988-01-19
K873971	Rotating Hemostatic Valve	Target Therapeutics	DTL	Class II	1988-01-19
K873792	Sepacell R-500 and Sepacell R-500A	Advocacy International, Ltd.	CAK	Class II	1988-01-19
K873775	Triad Nuclear Imaging System	Trionix Research Laboratory, Inc.	KPS	Class II	1988-01-19
K873576	Huchel Bodyliner	Hans-Juergen Huchel	IRT	Class II	1988-01-19
K873500	Mini Crosser Battery Powered Wheelchair	Heisteel DK ApS	INI	Class II	1988-01-19
K873472	Membrane Humidifier	Respiratory Support Products, Inc.	BTT	Class II	1988-01-19
K873457	Scented or Scented Deodorized Menstrual Pads	Procter & Gamble Mfg. Co.	HIL	Class II	1988-01-19
K873317	Ez Brush & Floss	Ez Products, Ltd.	EFW	Class I	1988-01-19
K873036	Attends Incontinent Brief	Procter & Gamble Mfg. Co.	EYQ	Class I	1988-01-19
K872815	Transjaw(tm)	Vitek, Inc.	BXB	Class I	1988-01-19
K872522	Bed Alert	Nite Train-R Enterprises, Inc.	KPN	Class II	1988-01-19
K870861	Uni-Vent(tm) Impact Minute Volume Ventilator	ZOLL Medical Corporation	CBK	Class II	1988-01-19
K873731	Safety Shield Kit	Ballard Medical Products	FXX	Class II	1988-01-15
K875190	Ultra Tan Purple Pro	Ultra Tan Intl. AB	LEJ	Class II	1988-01-14
K875189	Ultra Tan Purple Mint	Ultra Tan Intl. AB	LEJ	Class II	1988-01-14
K875177	J&j Scalp Vein Infusion Sets	Critikon Company, LLC	FOZ	Class II	1988-01-14
K875086	Orthomet Bone Plates	Orthomet, Inc.	HRS	Class II	1988-01-14
K875022	Ace/fisher Percutaneous Transfixing Pins	Buckman Co., Inc.	JDW	Class II	1988-01-14
K875013	Ace Percutaneous 3Mm Half-Pins	Buckman Co., Inc.	JDW	Class II	1988-01-14
K875012	Ace/fischer Percutaneous Half Pins	Buckman Co., Inc.	JDW	Class II	1988-01-14
K874543	Model Opo-32 Irrigation Sleeve	Allergan	EIB	Class I	1988-01-14
K874478	Dynafilm	Ferris Mfg. Corp.	NAD	Class I	1988-01-14
K874414	Hypodermic Needles, Single Lumen	Harbor Medical Devices, Inc.	FMI	Class II	1988-01-14
K874133	Mx710 Series Vascular Access Infusion Set	Medex, Inc.	FPA	Class II	1988-01-14
K873795	M-Lens (Thirty Degree Endoscope)	Opto Vision, Inc.	FEI	Class I	1988-01-14
K873619	Arthroscopic Retention-Manipulation System (Arms)	Arthropedics, Inc.	HRX	Class II	1988-01-14
K873205	Tympanic Temperature Sensor	Respiratory Support Products, Inc.	FLL	Class II	1988-01-14
K872768	Omniflex Normalized Hip Stem for Press-Fit Fixat.	Osteonics Corp.	KWA	Class III	1988-01-14