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 2878 of 3529

510(k) clearances, page 2878 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K855026	Acculevel Phenytoin Test	Syva / A Syntex Co.	DIP	Class II	1986-08-25
K854607	Acculevel Phenobarbital Test	Syva Co.	DLZ	Class II	1986-08-25
K863118	I.d.c. Standup Wheelchairs	Intl. Diffusion Consommateur	IPL	Class II	1986-08-21
K863027	Schirmer Peripheral Iridectomy Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1986-08-21
K862989	Surgical Drill (Electric) Including Handpiece	Entronics	HBC	Class II	1986-08-21
K862957	Merivaara Geriatric Chair Model 455	Global Medical Prods, Inc.	INN	Class I	1986-08-21
K862943	Site Disposable Fiberoptic Illuminator and Cable	Site Microsurgical Systems, Inc.	HQE	Class II	1986-08-21
K862869	Petrus Single Mirror Laser Lens	Ocular Instruments, Inc.	LQJ	Class II	1986-08-21
K862868	Abraham Yag Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1986-08-21
K862858	Cbc-Cal (Tm) Plus/multiple	R & D Systems, Inc.	KRX	Class II	1986-08-21
K862739	Intervascular Ochsner Micron Vascular Prostheses	Intervascular, Inc.	DSY	Class II	1986-08-21
K862728	Hoskins Nylon Suture Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1986-08-21
K862719	Solarshields	Dioptics	HQY	Class I	1986-08-21
K862713	Abraham Iridectomy Lens (Yag Laser)	Ocular Instruments, Inc.	HKS	Class I	1986-08-21
K862692	Karickhoff Diagnostic/laser Lens	Ocular Instruments, Inc.	HKS	Class I	1986-08-21
K862641	u.s. Diagnostic Inc. Hemoglobin Test (Dry Pack)	U. S. Diagnostics, Inc.	KHG	Class II	1986-08-21
K862323	Canon Non-Mydriatic Retinal Camera Cr4-45Nm	Canon Medical Components U.S.A., Inc.	HKI	Class II	1986-08-21
K862321	Cellmatics Rsv Detection System	Difco Laboratories, Inc.	LKT	Class I	1986-08-21
K862213	Pressure Control Valve & Tubing Cat. No. 83-1010	Lifestream Int'L, Inc.			1986-08-21
K862188	Irrigation & Aspiration/vitrectomy Device	Coburn Optical Ind., Inc.	HQE	Class II	1986-08-21
K862106	Formostar	Lmv, Liske & Methling, GmbH	IRT	Class II	1986-08-21
K861747	Keeler Fiberoptic Headlamp	Keeler Instruments, Inc.	HPQ	Class II	1986-08-21
K861746	Keeler Dual Lightsource	Keeler Instruments, Inc.	HPQ	Class II	1986-08-21
K863033	Patient Gas Sampling Kit/5stand Alone Versions	Intertech/Ohio	BZO	Class I	1986-08-20
K862998	Portable Isokinetics 3007 Back/abdomen Unit	Kent Design & Manufacturing, Inc.	IKK	Class II	1986-08-20
K862997	Portable Isokinetics 3005 Hip Unit	Kent Design & Manufacturing, Inc.	IKK	Class II	1986-08-20
K862996	Portable Isokinetics 3004 Knee Unit	Kent Design & Manufacturing, Inc.	IKK	Class II	1986-08-20
K862995	Portable Isokinetics 3003 Shoulder Unit	Kent Design & Manufacturing, Inc.	IKK	Class II	1986-08-20
K862994	Portable Isokinetics 3002 ISO Kane II	Kent Design & Manufacturing, Inc.	IKK	Class II	1986-08-20
K862993	Portable Isokinetics 3001 Wrist/ankle Unit	Kent Design & Manufacturing, Inc.	IKK	Class II	1986-08-20
K862961	Modified Surgical Starter Kit	Devon Industries, Inc.			1986-08-20
K862945	Downs Surgical Titanium Autocompression Plates	Downs Surgical, Ltd.			1986-08-20
K862935	Wound Manager(tm) - Sterile	Convatec, A Division of E.R. Squibb & Sons	NAD	Class I	1986-08-20
K862831	Modified Ohmeda Pac Portable Anesthesia System	GE Healthcare	BSZ	Class II	1986-08-20
K862228	Cabot Laser Laparoscopy Accessory Set	Cabot Medical Corp.	HHR	Class II	1986-08-20
K861014	Amplaid Mk15 (Evoked Potential System)	Amplaid USA, Inc.	GWL	Class II	1986-08-20
K860009	5.0 Mhz Meridian Ultrasound Imaging System	Johnson & Johnson Professionals, Inc.	ITX	Class II	1986-08-20
K854663	Neurofax 7310 Series (EEG)	Nihon Kohden America Inc	GWQ	Class II	1986-08-20
K854662	Oee_7102 Eeg/trend Monitor	Nihon Kohden America Inc	GWS	Class I	1986-08-20
K863145	Cervical Scrapers	Surgipath Medical Industries, Inc.	HHT	Class II	1986-08-19
K863002	Emds(tm) Magnesium Testpacks, #67671/95	Em Diagnostic Systems, Inc.	JGJ	Class I	1986-08-19
K863000	Astra 2,3,4 and 6: Chip Revision	Cardiac Pacemakers, Inc.			1986-08-19
K862964	Antiasthmatic Calibrators	American Monitor Corp.	DLJ	Class II	1986-08-19
K862956	Icon Reader	Hybritech, Inc.	JQT	Class I	1986-08-19
K862934	Hollister Female Urinary Collection Pouch	Hollister, Inc.	KNX	Class II	1986-08-19
K862871	Radioimmunoassay of No Spin(tm) Cortisol	Cambridge Medical Technology	CGR	Class II	1986-08-19
K862834	Model 115-16 Phosphorus (UV) Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CEO	Class I	1986-08-19
K862833	Model 303-47/303-48 Alanine Aminotransferase Kit	Diagnostic Chemicals, Ltd. (USA)	CKA	Class I	1986-08-19
K862818	Stratus Ferritin Fluorometric Enzyme Immunoassay	American Dade	JJE	Class I	1986-08-19
K862817	V-Trend Qc Tdm Control Serum 1,2,3.	Texas Immunology, Inc.	DIF	Class I	1986-08-19