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 2798 of 3530

510(k) clearances, page 2798 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872856	Biopro 32Mm Ball	Biopro, Inc.	JDI	Class II	1987-08-17
K872845	Bion Antinuclear Antibody(ana)test Kit/contr Serum	Bion Ent., Ltd.	DHN	Class II	1987-08-17
K872579	Innofluor Vancomycin Reagent Set	Innotron of Oregon, Inc.	LEH	Class II	1987-08-17
K872562	Innotron Innofluor Tobramycin Reagent Set	Innotron of Oregon, Inc.	LFW	Class II	1987-08-17
K872366	Aire-Cuf Polyester Re-Enforced Endotracheal Tube	Bivona Medical Technologies	BTR	Class II	1987-08-17
K872224	Modified Trochanter Cable Grip System	Howmedica Corp.	KTT	Class II	1987-08-17
K872214	Cooper Surg Aspiration Cannula/custom Conven Paks	CooperVision, Inc.	GEA	Class I	1987-08-17
K872172	Immubead Thyroid Uptake	IMMUNOTECH s.r.o.	KHQ	Class II	1987-08-17
K872027	Olympus Gf-Um2/eu-M2	Olympus Corp.	IYO	Class II	1987-08-17
K871539	Zindrick Im Rod	Buckman Co., Inc.	HSB	Class II	1987-08-17
K872982	Johnson & Johnson Absorbent Occlusive Dressing	Johnson & Johnson Professionals, Inc.	NAD	Class I	1987-08-14
K872850	Rate Infuser System	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1987-08-14
K872725	Model 100 Visual Evoked Response Recording System	Eyetronics, Inc.	GWE	Class II	1987-08-14
K872292	Transpect Transcranial Doppler	Medasonics, Inc.	IYN	Class II	1987-08-14
K872266	Clarified Applica. for Lacey Condylar Total Knee	Dow Corning Wright	JWH	Class II	1987-08-14
K872203	Cat. #9972 Refrigeration Medium (Test Yolk Buffer)	Irvine Scientific LLC	HDR	Class II	1987-08-14
K872089	Apaceram Hydroxylapatite Dental Implant (Type G)	Asahi Optical Co. C/O Rosati Associates, P.C.	DZE	Class II	1987-08-14
K872088	Freezing Medium (Test Yolk Buffer W/glycerol)	Irvine Scientific LLC	HDR	Class II	1987-08-14
K871212	Mascot Cw Doppler System	Imex Medical Systems, Inc.	JOP	Class II	1987-08-14
K870545	Andries Physical Assessment Computer	Andries Tek, Inc.	DQC	Class I	1987-08-14
K872975	Lightplast(tm)	Beiersdorf, Inc.	KGX	Class I	1987-08-13
K872886	Carbon Dioxide	Catachem, Inc.	KMS	Class II	1987-08-13
K872880	Calcitonin Ria Kit	Endocrine Associates, Inc.	JKR	Class II	1987-08-13
K872830	Biotrol Alt/tgp Monoreactif	Biotrol, USA, Inc.	CKA	Class I	1987-08-13
K872829	Biotrol Ast/tgo Monoreactif	Biotrol, USA, Inc.	CIT	Class II	1987-08-13
K872813	Easy St Analyzer System	Em Diagnostic Systems, Inc.	JJE	Class I	1987-08-13
K872580	Hr (Tm) Collection System	Abbott Medical	FMI	Class II	1987-08-13
K872197	Procedure No. 552/553 Bilirubin, Total and Direct	Sigma Diagnostics, Inc.	CIG	Class II	1987-08-13
K872192	Immubead T4 Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	KLI	Class II	1987-08-13
K872191	Immubead T3 Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	CDP	Class II	1987-08-13
K872175	Tdxr Flecainide	Abbott Medical	LBZ	Class II	1987-08-13
K872049	Novocheck/checkpoint/control Solution	Garid, Inc.	CGA	Class II	1987-08-13
K871603	Criterion II & Iia Oxygen Concentrators	Timeter Instrument Corp.	CAW	Class II	1987-08-13
K871265	Analyst(tm) Lipid Rotor & Hdl Calibrator/control	E.I. Dupont de Nemours & Co., Inc.	LBS	Class I	1987-08-13
K872910	Immuno/sle	Immunostics, Inc.	DHC	Class II	1987-08-12
K872894	A2j Mz 44 Laser Light for Positioning	Prometex, Inc.	IWE	Class I	1987-08-12
K872841	Acculite	Medical Alignment Systems	IWE	Class I	1987-08-12
K872834	Titan Gel Ife Antiserum to Igd-9409 & Ige-9410	Helena Laboratories, Corp.	CZJ	Class II	1987-08-12
K872800	Tdx Immunoglobulin G Diagnostic Kit	Abbott Medical	DEW	Class II	1987-08-12
K872485	Change of Catheter Body Material (Radio-Opaque Ny)	Ideas for Medicine, Inc.	DXE	Class II	1987-08-12
K872445	Power-Aid Independent X-Ray Power Source	Advanced Instrument Development, Inc.	IZO	Class I	1987-08-12
K872325	Gonostat Female Specimen Collection & Transport	Technology Management & Marketing, Inc.	JTW	Class I	1987-08-12
K872317	Bc 1800 Finger Positioner	Instrumentation Industries, Incorporated	KPR	Class II	1987-08-12
K872316	Bc 1400 Hand Positioner	Instrumentation Industries, Incorporated	KPR	Class II	1987-08-12
K872297	Ds-7 Nuclear Medicine Gamma Camera	Sopha Medical Systems, Inc.	IYX	Class I	1987-08-12
K872248	Double Lumen Catheter	Cordis US Corp.	DQO	Class II	1987-08-12
K872161	Dideco-Shiley Preassembled Surgical Wash Set	Shiley, Inc.	DTL	Class II	1987-08-12
K872159	Dideco-Shiley Autotransfusion Accessories	Shiley, Inc.	DWF	Class II	1987-08-12
K872150	I.s.g. 3Dmv Workstation	I.S.G. Technologies, Inc.	JAK	Class II	1987-08-12
K872121	K and D Home Tract	Joseph A. Kott, M.D.	HST	Class I	1987-08-12