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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3220 of 3528

510(k) clearances, page 3220 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821683	Reagent for Coulter Counter Model 5+11	Fisher Scientific Company L.L.C.	GIF	Class I	1982-06-24
K821682	Truncal Orthosis	Surgical Appliance Industries, Inc.	IQE	Class I	1982-06-24
K821680	Hollister Catheter Access. Port	Hollister, Inc.	EXB	Class I	1982-06-24
K821678	Autopak Estriol Test Delivery System	Micromedic Systems	CGI	Class I	1982-06-24
K821670	Argyle Tartan I Tracheal Tube	Sherwood Medical Co.	BTR	Class II	1982-06-24
K821667	Single Use Non-Conductive Circ. Discon	Vital Signs, Inc.	CAP	Class II	1982-06-24
K821665	Pedestal Examining Table	American Hamilton	GDC	Class I	1982-06-24
K821651	E-Z Up Artherapedic Chair	Medical Device Consultants, Inc.	INN	Class I	1982-06-24
K821632	Surgical Scissors, Set of 3	Fred Sammons, Inc.	FZT	Class I	1982-06-24
K821611	Gammadab [125] Fsh Radioimmunay Kit	Clinical Assays, Inc.	CGJ	Class I	1982-06-24
K821583	Ames/gilford Optimate Clin. Chem & Ther	Gilford Instrument Laboratories, Inc.	JJF	Class I	1982-06-24
K821773	Pedicraft Bed, Model B2944	Pedicraft, Inc.	FMS	Class II	1982-06-23
K821763	Shur-Strip Applicator	Shur Medical Corp.	FPX	Class I	1982-06-23
K821525	Deseret Universal Luer Lock	Warner-Lambert Co.	KGZ	Class I	1982-06-23
K821504	Thermal Well Temperature Sensor	Mon-A-Therm, Inc.	FLL	Class II	1982-06-23
K821500	Sterile Cath Care Kit	Pro-Pak	KDD	Class I	1982-06-23
K821476	Bard Endo Link Intracondylar Rotating	C.R. Bard Inc	KRO	Class II	1982-06-23
K821451	Vast Ventrex Allergy Systems Tests	Ventrex Laboratories, Inc.	DHB	Class II	1982-06-23
K821400	Mahurkar Subclavian Catheter	Quinton, Inc.	LFJ	Class II	1982-06-23
K821383	Echo, Model Mm-1000	Mesa Medical, Inc.	LIF	Class II	1982-06-23
K821268	Transducer Filter	Cp Medical	FIB	Class II	1982-06-23
K821260	Vitofit	Selomas, Inc.	FQL	Class I	1982-06-23
K821259	Vitasan	Selomas, Inc.	FQL	Class I	1982-06-23
K821256	Counter-Rotation System	The Langer Group	ITN	Class I	1982-06-23
K821157	Heterodynamic	Birtcher Corp.	IPF	Class II	1982-06-23
K821044	Patient Prep Kits/trays-Sterile	Phoenix Glove Co.	FRG	Class II	1982-06-23
K820988	Medtronic #1992-2 Dual Rate Transmitter	Medtronic, Inc.	GZB	Class II	1982-06-23
K820890	Urethane Orthopaedic Casting Tape	Hexcel Medical	ITG	Class I	1982-06-23
K820743	Hollow Fiber Dialyzers	Terumo Medical Corp.	FJI	Class II	1982-06-23
K813432	Hemodialysis System	Fhk	FKP	Class II	1982-06-23
K821727	Series 10 Liquid Chromotograph	Revvity Health Sciences, Inc.	LDM	Class I	1982-06-22
K821703	Mgn Conductive Connecting Tube, Sterile	Mgn Medical Manufacturing, Inc.	BYY	Class II	1982-06-22
K821698	Tdx Netilmicin	Abbott Medical	LCE	Class II	1982-06-22
K821690	Erika Hpf 100,200,300 Dialyzer	Erika, Inc.	FJI	Class II	1982-06-22
K821688	Titan Gel High Resolution Serum Protein	Helena Laboratories, Corp.	JJN	Class I	1982-06-22
K821677	The Communicator	Robert Swinney., Ltd.	ILQ	Class II	1982-06-22
K821675	Calcitonin Ria Test Kit, Dls 1200	Diagnostic Systems Laboratories, Inc.	JKR	Class II	1982-06-22
K821674	Spinchem Acid Phosphatase Reagent	Smithkline Diagnostics, Inc.	CKB	Class II	1982-06-22
K821661	Flexiflo-II	Abbott Medical	FRN	Class II	1982-06-22
K821648	Gas Chex Plastic Bag	Propper Mfg Co Inc	JOJ	Class II	1982-06-22
K821624	Low Volume Infustion Set	Lifemed of California	FPA	Class II	1982-06-22
K821591	Steam Sterilization Equipment	Getinge International, Inc.	FLE	Class II	1982-06-22
K821588	Sandhill Dms	Sandhill	KLA	Class II	1982-06-22
K821578	Venoset Dual-Rate Piggyback W/ivex &	Abbott Medical	FPA	Class II	1982-06-22
K821551	Martin-Lewis/prong Agar	Gibco Laboratories Life Technologies, Inc.	JTY	Class II	1982-06-22
K821496	Disposable Irriga/aspir. System	Innovative Surgical Products, Inc.	KDH	Class II	1982-06-22
K821272	Bn-74 Coated Bardex All Silicone Cath	C.R. Bard Inc	KOD	Class II	1982-06-22
K821264	Cefoperazone 75Mcg Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1982-06-22
K821262	Cefoperazone 75Mcg Sensit- Discs	Difco Laboratories, Inc.	JTN	Class II	1982-06-22
K821252	Hoffman Universal Foot Support	Howmedica Corp.	KQZ	Class I	1982-06-22