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 2026-10-12, 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 3248 of 3528

510(k) clearances, page 3248 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820048	Fsh Radioimmunoassay Test System	Monobind, Inc.	CGJ	Class I	1982-02-04
K820037	Sickle-Check	Diagnostic Technology, Inc.	JCM	Class II	1982-02-04
K820031	Cadwell 5200	Cadwell Laboratories, Inc.	JXE	Class II	1982-02-04
K820027	Modified Ea 50	Surgipath	HZJ	Class I	1982-02-04
K820018	Comfeel Protective Sheet	Telecam Medical Devices	KGX	Class I	1982-02-04
K820004	Pleurofix Thoracentesis Kit	Burron Medical Products, Inc.	GAZ	Class II	1982-02-04
K813637	Stoltronics-Lrs	Stoltronic Systems, Inc.	KCW	Class I	1982-02-04
K813615	Chl	Dms Laboratories	JSC	Class I	1982-02-04
K813614	Staph Trac	Dms Laboratories	JWX	Class I	1982-02-04
K813611	Che	Dms Laboratories	JSC	Class I	1982-02-04
K813610	Rapid Strep	Dms Laboratories	JTO	Class I	1982-02-04
K813609	Rapid E	Dms Laboratories	JSS	Class I	1982-02-04
K813588	Ctf Model 9300	Thomson-Csf Broadcast, Inc.	IZI	Class II	1982-02-04
K813535	Xeroform Dressing	W.G. Whitney Corp.	FRO	Unclassified	1982-02-04
K813500	Oms Infusion-Aspiration Handle	Optical Micro Systems, Inc.	HQE	Class II	1982-02-04
K813475	Xomed Micro-Irrigator	Xomed, Inc.	FQH	Class II	1982-02-04
K813389	Ultrasonic Fragmentor	Fibra Sonics, Inc.	HQE	Class II	1982-02-04
K813375	Hematology Calibrator S-Cal	Coulter Electronics, Inc.	KSA	Class II	1982-02-04
K813365	Multiple Bandage or Dressing	Cederroth, Inc. USA	FRO	Unclassified	1982-02-04
K813254	Jet Ventilator	Healthdyne, Inc.	CBK	Class II	1982-02-04
K813052	Ultracast Waterless Synthetic Resin Cast	Zimmer GmbH	ITG	Class I	1982-02-04
K812905	Permanent Endocard. Unipolar Tined Lead	Diag Corp.	DTB	Class III	1982-02-04
K812005	Capillary Perfusion Monitor #Ld5000	Nuclear Pacific, Inc.	DPW	Class II	1982-02-04
K820165	Flow Med 311	D.R.O. Medical, Inc.	FMG	Class II	1982-02-01
K820153	Exacon Scientific Instruments Aps	Sat Export Engineering & Trading	FLL	Class II	1982-02-01
K813562	Syringe Driver 209	Medix Medical Electronics (U.S.A.), Inc.	FRN	Class II	1982-02-01
K827885	Bio-Derm Coupling Lotion	Whs Products, Inc.	HGL	Class II	1982-01-29
K820175	O.n.a.t.	Latex Medical Devices, Inc.	KNC	Class II	1982-01-29
K820152	Key Med Leeds Endoscope Disinfector	Keymed, Inc.	FEB	Class II	1982-01-29
K820150	K-Aid	Sytek Laboratories	KPO	Class II	1982-01-29
K820136	Urinary Drainage Bag	Megaplast, Inc.	KNX	Class II	1982-01-29
K820129	Advance System Emit-Amd Tobramycin Cntrl	Syva Co.	LAS	Class I	1982-01-29
K820120	Patient Guided Knee Exerciser	Richard'S Medical Equip., Inc.	BXB	Class I	1982-01-29
K820109	Radiation Sterilized Suction Catheters	Travenol Laboratories, S.A.	BSY	Class I	1982-01-29
K820102	Subclavian Jugular Catheter Set	Luther Medical Products, Inc.	DQR	Class II	1982-01-29
K820094	Elastic Bandage	Stan-Pak Ent.	FQM	Class I	1982-01-29
K820051	Obus Forme Orthopedic Brace, Upright	Obus Forme, Ltd.	IQE	Class I	1982-01-29
K820046	Anesthesiology Devices	Bentley Laboratories, Inc.	DRS	Class II	1982-01-29
K820045	Cardiovascular Devices	Bentley Laboratories, Inc.	DTM	Class II	1982-01-29
K820019	Piperacillin 100Mcg. Antimicrobial	General Diagnostics	JTN	Class II	1982-01-29
K820007	Neisseria Gonorrhoeae Test	New Horizons Diagnostics Co.	LIC	Class II	1982-01-29
K820001	Coronary Infusion Kit	Mallinckrodt Critical Care	DQO	Class II	1982-01-29
K813602	Holter Performer	Applied Cardiac Systems	DSH	Class II	1982-01-29
K813586	Dialysis Concentrate	Diversified Medical Services	KPO	Class II	1982-01-29
K813577	Pressure Indicator-Regulator	Advanced Catheter Systems	DQO	Class II	1982-01-29
K813568	Estilux Posterior Xr	Kulzer GmbH	EBF	Class II	1982-01-29
K813561	Spectrum Pediatric Cardle Table	Spectrum X-Ray Corp.	KXH	Class I	1982-01-29
K813560	Liquizyme Creatinine Reagent Set	Amresco, Inc.	CGX	Class II	1982-01-29
K813506	Farrors Tmj Cassette Holder	Brell Mar Products, Inc.	KXF	Class I	1982-01-29
K813486	Teletred Gait Analysis System	Structural Analysis Systems, Inc.	IOL	Class I	1982-01-29