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 2854 of 3529

510(k) clearances, page 2854 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863903	Sea Med Model 6000	Seamed Corp.	DTE	Class II	1986-12-10
K863879	Neos-M Vs-1 Pulse Generator	Biotronik Sales, Inc.	DXY	Class III	1986-12-10
K863878	Trios-M Vs-1 Pulse Generator	Biotronik Sales, Inc.	DXY	Class III	1986-12-10
K863652	Model 456 Electrocardiorecorder Recorder	Del Mar Avionics	DPS	Class II	1986-12-10
K863112	Proteinmeter	J. D. Assoc.	JGP	Class II	1986-12-10
K863068	Ldh S.c.e.	J. D. Assoc.	CFJ	Class II	1986-12-10
K863053	Alt S.c.e. (Gpt)	J. D. Assoc.	CKA	Class I	1986-12-10
K864508	Howse II Total Hip Replacement System	Johnson & Johnson Professionals, Inc.			1986-12-09
K864479	Caretex Isolution Gowns	James River Corp.	FYC	Class II	1986-12-09
K864413	Model Hse-5M Microwave Surgery Equipment/microtaze	Cooper Lasersonics, Inc.	KNS	Class II	1986-12-09
K864381	Luxtec Videolux 20/20 Camera Headlight System	Luxtec Corp.	FWC	Class I	1986-12-09
K863304	Preselected Flow Rate i.v. Set	Simplivia Healthcare Ltd.	FPA	Class II	1986-12-09
K862849	Hemoccult Wipe Test	Smithkline Diagnostics, Inc.	KHE	Class II	1986-12-09
K862838	Cytotech Hsv Igg Enzyme Immunoassay	Cytotech, Inc.	GCO	Class II	1986-12-09
K863584	Em II Stress Test Electrode	Electromed Intl., Ltd.	DRX	Class II	1986-12-08
K863540	Em II Disposable Electrode	Electromed Intl., Ltd.	DRX	Class II	1986-12-08
K863468	Exactech(tm)	Travenol Laboratories, S.A.	CGA	Class II	1986-12-08
K860948	Tracker System	Boehringer Mannheim Corp.	CGA	Class II	1986-12-08
K860854	Criticalc	Cygnus of South Florida, Inc.	DQK	Class II	1986-12-08
K864585	Acs Hi-Torque Floppy Guide Wire, 0.018 Inch	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1986-12-05
K864564	Model 486-05 Polyflex(r) Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-12-05
K864428	Model 366-23 Adaptaid(tm) Step-Down Adapter	Intermedics, Inc.	DTB	Class III	1986-12-05
K864394	Emerson 3Mv Volume Ventilator	J. H. Emerson Co.			1986-12-05
K864147	Aquavalve	Respiratory Care, Inc.	BYH	Class I	1986-12-05
K864098	Telectronics Srew-In/slim Line Pacing Leads	Daig Corp.	DTB	Class III	1986-12-05
K864053	Tubulitec Liner	Dental Dimensions Supply Co.	EJK	Class II	1986-12-05
K864052	Tubulitec Primer	Dental Dimensions Supply Co.	LBH	Class II	1986-12-05
K864050	Tubulicid Blue Label	Dental Dimensions Supply Co.	LBH	Class II	1986-12-05
K863792	Duracath, Gish Model No. Dvac-Xxxx	Gish Biomedical, Inc.	BSO	Class II	1986-12-05
K863643	Epicardia, Pc/fd	Medicomp, Inc.	DSI	Class II	1986-12-05
K863046	Ultra Software Module: Model 2016	Cardiac Pacemakers, Inc.	KRG	Class III	1986-12-05
K862697	Avtech Lwp(low Porosity) Mwp(medium Porosity)	Advanced Vascular Technologies, Inc.	DSY	Class II	1986-12-05
K862463	Lifescope 8, Oec-8120 Portable Patient Monitor Rec	Nihon Kohden America Inc	DRT	Class II	1986-12-05
K860814	Dsp100 Amplifier	Intl. Acoustics, Inc.	DQC	Class I	1986-12-05
K864389	Chlamydiae Flourescent Monoclonal Antibody Test	American Micro Scan	LJP	Class I	1986-12-04
K864298	Zenex Medical, Inc. Gauze Sponges	Zenex Medical, Inc.	EFQ	Unclassified	1986-12-04
K864283	Simplastin Excel	bioMerieux, Inc.	GJS	Class II	1986-12-04
K864231	u.s. Diagnostics Enzymatic Triglyceride Test	U. S. Diagnostics, Inc.	CDT	Class I	1986-12-04
K864212	Il Test 97573-15, Plasminogen Assay	Instrumentation Laboratory Co.	DDX	Class I	1986-12-04
K864189	Ultra-Gel - #4083	John F. Greer Co., Inc.	EXB	Class I	1986-12-04
K864188	E-Z Hold with Adhesive Base.-#4065	John F. Greer Co., Inc.	KNX	Class II	1986-12-04
K864182	Enteral Administration Adapters	Biosearch Medical Products, Inc.	KNT	Class II	1986-12-04
K864082	Reflotron(r) Alt (Gpt)	Boehringer Mannheim Corp.	CKD	Class I	1986-12-04
K864081	u.s. Diagnostics Serum Cholesterol Test	U. S. Diagnostics, Inc.	CHH	Class I	1986-12-04
K864038	Supercath i.v. Catheter	Togo Medikit Co., Ltd.	FOZ	Class II	1986-12-04
K863980	u.s. Diagnostics Alkaline Phosphatase Test	U. S. Diagnostics, Inc.	CJE	Class II	1986-12-04
K863928	Terumo Sensibead Eia Fsh Kit	Terumo Medical Corp.	CGJ	Class I	1986-12-04
K863086	Sapphire Laser Blades (Laser Blades) Nd: Yag	Cooper Lasersonics, Inc.	GEX	Class II	1986-12-04
K863066	Transfermeter	J. D. Assoc.	JQF	Class I	1986-12-04
K862806	Urine Diagnostic Reagent Strips	Amatech International, Inc.	JJB	Class I	1986-12-04