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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2950 of 3529

510(k) clearances, page 2950 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853577	Medipart Bacteria Filter Mp-2615	Medipart Jerry Alexander	CAH	Class II	1985-10-30
K853459	Xeroradiography Liquid Toner Imaging System	Xerox Medical Systems	IXK	Class II	1985-10-30
K854067	Select Flowmeter	Precision Medical, Inc.	CAX	Class I	1985-10-29
K854004	Fluorescent T12 Uva Tanning Lamp	Light Sources, Inc.	FTC	Class II	1985-10-29
K853846	Sun Tanning Bed	Tan America Mfg.	FTC	Class II	1985-10-29
K853828	Fls Med. Prod. Racine Type Adaptor	Fls Medical Products, Inc.	BZA	Class I	1985-10-29
K853756	Dynamic Cardiac Phantom 74-347	Victoreen, Inc.	IXY	Class I	1985-10-29
K853640	Wellington Hospital Pattern Self Retaining Vaginal	Downs Surgical, Ltd.	HDF	Class I	1985-10-29
K853578	Medipart Dispos. Nose Clip Mp-2001	Medipart Jerry Alexander	BXJ	Class I	1985-10-29
K853575	Medipart Mouthpiece Mp-1010	Medipart Jerry Alexander	BYP	Class I	1985-10-29
K853574	Medipart Dispos. Mouthpiece W/22mm O.d. Mp-4411	Medipart Jerry Alexander	BYP	Class I	1985-10-29
K853573	Medipart Face Mask Headstrap Mp-9100	Medipart Jerry Alexander	BTK	Class I	1985-10-29
K853572	Medipart Dispos. Mouthpiece W/2mm I.d. Mp-4410	Medipart Jerry Alexander	BYP	Class I	1985-10-29
K853571	Medipart Soda Lime Mp-3522	Medipart Jerry Alexander	CBL	Class I	1985-10-29
K853481	Vistech Vcts Glare Tester	Vistech Consultants, Inc.	HOX	Class I	1985-10-29
K853266	Plastic Mouth Barrier Hsv-I	Westmark Enterprises, Inc.	BYP	Class I	1985-10-29
K853169	Gt Hip Prosthesis Femoral Component	Intermedics Orthopedics	JDI	Class II	1985-10-29
K853138	Millar Mikro-Tip Doppler Catheter	Millar LLC.	JOP	Class II	1985-10-29
K852839	Freeman Hip	Advanced Biosearch Assn.	JDI	Class II	1985-10-29
K852823	Dma Oxygen Monitor	Ferguson Medical	CCL	Class II	1985-10-29
K851265	Peak Flowmeters for Spirometry	Solcoor, Inc.	BZH	Class II	1985-10-29
K851164	Dentocult Culture-Paddle	Orion Corp.	JJJ	Class I	1985-10-29
K844446	Bisico Sl(putty) Bisico S2(regular) S3 Heavy Etc.	Pulpdent Corp. of America	ELW	Class II	1985-10-29
K854251	The Cse Film Changer System	Changer Service & Engineering, Inc.	IZP	Class II	1985-10-28
K854085	Omni Plane System	Xre Corp.	IXR	Class II	1985-10-28
K854044	Tdx Barbiturates	Abbott Medical	LGQ	Class II	1985-10-28
K854039	Laser Aso Kit	Behring Diagnostics, Inc.	GTQ	Class I	1985-10-28
K854025	Hitachi 704	Boehringer Mannheim Corp.	JJE	Class I	1985-10-28
K853928	Universal Stand for Film Changer	Canon Medical Components U.S.A., Inc.	KPX	Class II	1985-10-28
K853879	Tdx Amphetamine Methamphetamine	Abbott Medical	DKZ	Class II	1985-10-28
K853854	Astra Systems Cholesterol Reagent	Beckman Instruments, Inc.	CHH	Class I	1985-10-28
K853681	Sigma 610 for Protein in Urine & Csf	Sigma Diagnostics, Inc.	CEK	Class II	1985-10-28
K853412	Wave Gate	Wolfline Corp.	GWE	Class II	1985-10-28
K853349	Varian Ximatron C-Series Radiotherapy Treatment St	Varian Assoc., Inc.	KPQ	Class II	1985-10-28
K853181	Vickers Ergomatic Micros Instr-Fine R or L Handed	Keeler Instruments, Inc.	GZX	Class I	1985-10-28
K853180	Vickers Ergomatic Micros Instr-Long R or L Handed	Keeler Instruments, Inc.	GZX	Class I	1985-10-28
K852410	Mevaplan and Somados	Siemens Medical Solutions USA, Inc.	KPQ	Class II	1985-10-28
K854119	Accuracy	Columbia Diagnostics, Inc.	JJY	Class I	1985-10-25
K854092	Dma Calibrators	Data Medical Associates, Inc.	JIX	Class II	1985-10-25
K854087	Nml Tsh Irma	bioMerieux, Inc.	JLW	Class II	1985-10-25
K854063	Microvasive Silicone Spray	Microvasive	KCT	Class II	1985-10-25
K853904	Endo-Lase Cd40 for Urology	Endo Lase, Inc.	GEX	Class II	1985-10-25
K853874	Endo-Lase Cd-100 CO2 Laser for External Genitalia-	Endo Lase, Inc.	GEX	Class II	1985-10-25
K852737	Lactoplate	Mackeen Consultants, Ltd.	DEG	Class I	1985-10-25
K853861	Canon X-Ray i.i. Rapid Sequence Camera Crs-105	Canon Medical Components U.S.A., Inc.	IJZ	Class I	1985-10-24
K853833	Top Sun Models 100,101,103 &139, 139-1, 139-3	Top Sun America, Inc.	FTC	Class II	1985-10-24
K853519	Lifeline Endocardial Bipolar Lead 484-03	Intermedics, Inc.	DTB	Class III	1985-10-24
K852974	Acuson Radiology Doppler Accessory	Acuson Computed Sonography	ITX	Class II	1985-10-24
K852816	Freedom Line Lubricated Models Ls-2-5, Lt-6-10	Apollo Dental Products, Inc.	EIA	Class I	1985-10-24
K851522	Diagnostic ECG Disposable Electrode	Sentry Medical Products, Inc.	DRX	Class II	1985-10-24