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 2026-10-05, 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 3500 of 3526

510(k) clearances, page 3500 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770245	Abdominal Fetal ECG Module	Mennen Greatbatch Electonics	KXN	Class II	1977-02-14
K770243	Elgiloy Stylet	Cardiac Pacemakers, Inc.	DRR	Class II	1977-02-14
K770241	Neonatal T4 Ria Kit	Siemens Healthcare Diagnostics Inc.	CDX	Class II	1977-02-14
K770240	Treadmill Stress Exercise System	Burdick Corp.	IOL	Class I	1977-02-14
K770239	Digital Heart Rate Meter	Burdick Corp.	DRT	Class II	1977-02-14
K770234	Model 880 Rehabilitation Trainer	Quinton, Inc.	ISD	Class II	1977-02-14
K770232	Blood/fluid Warmer Model Dw-1000A	Gorman Rupp Industries	BSB	Class II	1977-02-14
K770210	Analytix Auto Sample Prep. Sta. 1600	G.D. Searle and Co.	JQW	Class I	1977-02-14
K770194	Naso-Lacrimal Duct Insert	Concept, Inc.	HNL	Class I	1977-02-14
K770136	Disposable Bacteria Filter	Omnicon Medical Corp.	CAH	Class II	1977-02-14
K770088	Gamma 4000 Scintillation Counter	Beckman Instruments, Inc.	JJJ	Class I	1977-02-14
K770087	i.v. Pump, Abbott/shaw Lifecare	Abbott Medical	FRN	Class II	1977-02-14
K761280	Auto Creatinine Reagent (Gilford 3400-E)	Harleco	CGX	Class II	1977-02-14
K761271	Urin. L7-Oh Corticosteroid T(non Hydro)	Eppendorf-Brinkmann, Inc.	CDB	Class I	1977-02-14
K770142	Sma Reference Serum 3	Technicon Instruments Corp.	JIX	Class II	1977-02-11
K761279	Auto Creatinine Reagent (Abbott System)	Harleco	CGX	Class II	1977-02-11
K761148	Reflomat/reflotest System	Boehringer Mannheim Corp.	CGA	Class II	1977-02-11
K770218	Shiley Pediatric Murphy Endotrach. Tube	Shiley, Inc.	BTO	Class II	1977-02-09
K770183	O.22/um Filterset W/flashback	Abbott Medical	FPB	Class II	1977-02-09
K770162	Maternity Supporter	R.G. Moore	FSD	Class I	1977-02-09
K761281	Data-Tope T3 Uptake Procedure	Dade, Baxter Travenol Diagnostics, Inc.	KHQ	Class II	1977-02-09
K770206	Grasping Forceps	Depuy, Inc.	HTD	Class I	1977-02-08
K770205	Cement Chisels	Depuy, Inc.	HWA	Class I	1977-02-08
K770204	Cement Extractor Drill	Depuy, Inc.	HXY	Class I	1977-02-08
K770203	Hand Reamers	Depuy, Inc.	HTO	Class I	1977-02-08
K770184	Bi-Centric Endoprostheses	Howmedica Corp.	JDG	Class II	1977-02-08
K770173	Stockinette	Chase Mfg. Co.	ILG	Class I	1977-02-08
K770153	Camco R Pak-Guaiac	Cambridge Chemical Products, Inc.	KHE	Class II	1977-02-08
K770051	Venoset for i.v. Fat Emulsion	Abbott Medical	FPA	Class II	1977-02-08
K770213	Barior	Tri-Med, Inc.	KOC	Class II	1977-02-07
K770202	Ctm (Clinac Treatment Monitor)	Varian Assoc., Inc.	KPQ	Class II	1977-02-07
K770199	Lead Extender Model 6516	Cardiac Pacemakers, Inc.	DTD	Class II	1977-02-07
K770198	Bipolar Asynchronous Pulse Generator	Cardiac Pacemakers, Inc.	DXY	Class III	1977-02-07
K770197	Unipolar, Asynchronous Pulse Generator	Cardiac Pacemakers, Inc.	DXY	Class III	1977-02-07
K770195	Perm. Implant. Endocardial Pac. Lead	Daig Corp.	DTB	Class III	1977-02-07
K770172	Pellet, Calibration	Deringer-Ney, Inc.			1977-02-07
K770157	Devilbiss Oxygen Enricher	The Devilbiss Co.	CAW	Class II	1977-02-07
K770156	Spac Tm T4 Ria Kit	Mallinckrodt Critical Care	CDX	Class II	1977-02-07
K770135	Lead Modification	Elema-Schonander, Inc.	DXY	Class III	1977-02-07
K770033	Spac Tm T3 Uptake Kit	Mallinckrodt Critical Care	KHQ	Class II	1977-02-07
K761317	Hga-2200 Heated Graphite Atomizer	Revvity Health Sciences, Inc.			1977-02-07
K761316	Absorption Spectrophotometers	Revvity Health Sciences, Inc.	JXR	Class I	1977-02-07
K761137	Microsample Blood Collection Device	Ortho Diagnostics, Inc.	GKH	Class I	1977-02-07
K761058	Quan-8 Mult-Comp Factor VIII Assay Kit	Bio/Data Corp.	GGP	Class II	1977-02-07
K770175	Sea-Bond Adhevise Denture Cushions	Combe, Inc.	KKX	Class II	1977-02-04
K770147	Avon Tilting Push Chair 14	Maddak, Inc.	IQC	Class II	1977-02-02
K770065	Adjustable Arm Support	Richard F. Kronner, M.D.	IOY	Class I	1977-02-02
K761351	L080 Series Liquid Chromatograph	Hewlett-Packard Co.	KIE	Class I	1977-02-02
K770178	Stoma Bags W/microporous Adhesive	Hollister, Inc.	EXB	Class I	1977-02-01
K770150	Electro Immuno Assay Kit	EMD Millipore Corporation	JZS	Class I	1977-02-01