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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3418 of 3526

510(k) clearances, page 3418 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781951	Antisera, Rhodamine Conjugated Fragment	Kallestad Laboratories, Inc.	DCE	Class I	1979-02-16
K790182	2 Velcro Splint Strap	Fred Sammons, Inc.	ILH	Class I	1979-02-15
K790169	Tomographic Programs	Cmsi	KPS	Class II	1979-02-15
K790168	Collimator, Bilaterial	Cmsi	KQA	Class II	1979-02-15
K790145	Solvent Delivery System	Waters Assoc., Inc.	KIE	Class I	1979-02-15
K790122	Rubanon	Organon LLC	GOK	Class II	1979-02-15
K790110	Preparation, Dupont	E.I. Dupont de Nemours & Co., Inc.			1979-02-15
K790042	Stain, Hemastain Retic	Geometric Data, Div. Smithkline Corp.	GJH	Class I	1979-02-15
K790028	Diluent, Cellent Blood	Sysmex Corporation	GIF	Class I	1979-02-15
K790021	Serum, Inorganic Phosphorous	Fisher Scientific Company L.L.C.	CEO	Class I	1979-02-15
K790016	Serum, Glutamic-Pyruvic	Fisher Scientific Company L.L.C.	CKA	Class I	1979-02-15
K790015	Serum, Creatinine Phosphokinase	Fisher Scientific Company L.L.C.	JHS	Class II	1979-02-15
K782175	Cartridge Holder, Rcm 100	Waters Assoc., Inc.	KIE	Class I	1979-02-15
K782170	Seracon-Lp	Bhp Diagnostix, Inc.	JJX	Class I	1979-02-15
K782150	Flurometer, Dade	Dade, Baxter Travenol Diagnostics, Inc.	JZT	Class I	1979-02-15
K782130	Mini-Diluter 2	Dynatech Laboratories, Inc.	JQW	Class I	1979-02-15
K782126	Ria Kit, Sisomicin	Siemens Healthcare Diagnostics Inc.	DJB	Class II	1979-02-15
K782062	Analyzer, Oxygen Model M25ra & M25rad	Catalyst Research Corp.	CCL	Class II	1979-02-15
K781918	Irrigator, Body Cavity	Bci, Inc.	EYN	Class II	1979-02-15
K781755	Dap-Pak	Dravon Medical, Inc.	KDJ	Class II	1979-02-15
K781479	Heparin Assay	Dade, Baxter Travenol Diagnostics, Inc.	KFF	Class II	1979-02-15
K790265	Levo-Stand-Up Wheelchair	Marion Laboratories, Inc.	IPL	Class II	1979-02-13
K790262	Universal External Fixation Assembly	Zimmer GmbH	JEC	Class II	1979-02-13
K790259	Sterile Disposable Knife	Intermedics, Inc.	GDX	Class I	1979-02-13
K790181	Soft Splint Straps	Fred Sammons, Inc.	ILH	Class I	1979-02-13
K790180	Platform Splints	Fred Sammons, Inc.	ILH	Class I	1979-02-13
K790170	Bk-1472 Spatula Spoon	Fred Sammons, Inc.	ILC	Class I	1979-02-13
K790135	Monitor, Pressurveil	Concept, Inc.	DSK	Class II	1979-02-13
K782169	Needles, Cannulas, Cystotomes	Visitec Co.	HMX	Class I	1979-02-13
K781922	Pulmonary Monitor	Vitalograph, Inc.	BZH	Class II	1979-02-13
K790244	Cystotomes	Visitec Co.	HNY	Class I	1979-02-12
K790243	Cannulas	Visitec Co.	HMX	Class I	1979-02-12
K790238	Transverse Traction Assembly	Zimmer GmbH	KWP	Class II	1979-02-12
K790228	Earette Hearing Aid	Oticon, Inc.	ESD	Class I	1979-02-12
K790216	Ventilation Tube, Sheehy Collat	Xomed, Inc.	ETD	Class II	1979-02-12
K790190	Tinnitus Maskers Model S584	Vican Instrument Co.	KLW	Class II	1979-02-12
K790102	Model 556-01 Cryoextractor	Intermedics, Inc.	HPS	Class II	1979-02-12
K790023	Occular Compu-Scan	Storz Instrument Co.	IYO	Class II	1979-02-12
K782140	Remover, Soft-Sert Contact Lens	Mcmurray and Pendergost	KYE	Class I	1979-02-12
K781994	Autokeratometer, Instrument	Zeiss Humphrey System	HLQ	Class I	1979-02-12
K781338	Beaver Cataract Cyroxtractor	Edward Weck, Inc.	HPS	Class II	1979-02-12
K790033	Hvg-100	Elmed, Inc.	IPF	Class II	1979-02-09
K781960	Surgical Eye Shield	Concept, Inc.	HJK	Class II	1979-02-09
K781870	Implant, H.p. Condylar	Dow Corning Corp. Healthcare Industries Materials	KWD	Class II	1979-02-09
K790233	Electrocardiograph, at-300 3 Channel	Health Technology Laboratories, Inc.	DPS	Class II	1979-02-08
K790192	Sarno Single Pole Mast	Sames, Inc.	KRI	Class I	1979-02-08
K790191	Visa-Grip	Premier Sundries, Inc.	ION	Class I	1979-02-08
K790189	Electreat Model 250 Transcutaneous Stim	Electreat, Inc.	GZJ	Class II	1979-02-08
K790179	Gair Training Belt	Fred Sammons, Inc.	ISR	Class I	1979-02-08
K790178	Water Powered Bath Chair Lift	Fred Sammons, Inc.	ILS	Class I	1979-02-08