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 2877 of 3529

510(k) clearances, page 2877 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860682	Gambro Analyz Mon Glucose/am-G & Disp Am-G Tub Set	Gambro, Inc.	CGA	Class II	1986-08-29
K860678	J.k. Templeton Ear Piercing Guns/instruments/studs	Jay Kenny Templeton	JYS	Class I	1986-08-29
K862798	Miniox 100 Pulse Oximeter	Catalyst Research Corp.	DQA	Class II	1986-08-28
K862464	Schneider-Shiley Y-Connector with Rotator	Shiley, Inc.	DQO	Class II	1986-08-28
K861851	Siemens-Elema (Sicard-P)	Mortara Instrument, Inc.	DPS	Class II	1986-08-28
K861850	Burdick Division (E-500)	Mortara Instrument, Inc.	DPS	Class II	1986-08-28
K861761	Accessus Dry Storage Package Sterile Comp Storage	Travenol Laboratories, S.A.	LPZ	Unclassified	1986-08-28
K861493	Oscor Medical Fix Screw Pacing Lead/peelable Cath	Oscor Medical Corp.	DTB	Class III	1986-08-28
K854790	Ceryx Pacemaker Models 114, 314 & 614	Vitatron Medical BV	DXY	Class III	1986-08-28
K863179	Kimlon Disposable Blanket	Kimberly-Clark Corporation	KME	Class I	1986-08-27
K863164	Agar Reduction in Formula for Pdc 110 & 310 Media	Precision Dynamics Corporation	JSM	Class I	1986-08-27
K862960	Phase II Ferritin Radioimmunoassay Kit	Medical & Scientific Designs, Inc.	DBF	Class II	1986-08-27
K862927	Cadd-1, Model 5100 HF	Deltec Systems, Inc.	FRN	Class II	1986-08-27
K862491	Exel Butterfly Scalp Vein Set	Exel Intl.	FPA	Class II	1986-08-27
K862332	Anaerobe Rapid Chromogenic Id Panel	American Micro Scan	JSP	Class I	1986-08-27
K862231	Empi, Model 1000 Hand Held Electrode	Empi	GXY	Class II	1986-08-27
K861563	Vitaguard Percutaneous Infection Control Kit	Vitaphore Corp.	LJS	Class II	1986-08-27
K860952	i.v. Set with and without Air Vent	Simplivia Healthcare Ltd.	FPA	Class II	1986-08-27
K855046	Tdx Immunoglobulin a Diagnostic Kit	Abbott Medical	CZP	Class II	1986-08-27
K854944	Tdx Immunoglobulin M Diagnostic Kit	Abbott Medical	DAH	Class II	1986-08-27
K863196	Bun (Rate) Reagent	Sigma Diagnostics, Inc.	CDQ	Class II	1986-08-26
K863141	Kulzer Glass Ionomer Liner	Shofu Dental Corp.	EMA	Class II	1986-08-26
K863131	Pik Pocket (Irrigating Tip)	Teledyne, Inc.	EFS	Class I	1986-08-26
K863097	Cb Bur	Beavers Dental, Div. Sybron Canada, Ltd.	EJL	Class I	1986-08-26
K863026	Pulmanex Tm (Modification)	Life Design Systems, Inc.	BTM	Class II	1986-08-26
K862980	Oticon I31 Cite Hearing Aid	Oticon, Inc.	ESD	Class I	1986-08-26
K862856	Palladium Based Dent Alloys/porcelain Metal Restor	Austenal Dental, Inc.	EJS	Class II	1986-08-26
K862638	Visible-Chlamydia(tm) Test System	Isolab, Inc.	LJC	Class I	1986-08-26
K862065	Pc-Plan	Dosimetrix, Inc.	IYE	Class II	1986-08-26
K861414	Electrophoresis Work Center (Ewc)	Helena Laboratories, Corp.	JJN	Class I	1986-08-26
K861386	Kodak Ektachem Clinical Chemistry Slides (Mg)	Eastman Kodak Company	JGJ	Class I	1986-08-26
K861199	Bunn Model 22 Oxygen Flow Controller	The John Bunn Co.	NFB	Class II	1986-08-26
K862971	Micra Microsurgical Instruments	Cordis US Corp.	GZX	Class I	1986-08-25
K862953	Classic Resting Silver-Silverchloride Electrode	Classic Medical Products, Inc.	DRY	Class II	1986-08-25
K862880	Sara Rt	Alleghany Intl. Medical Technology	CCK	Class II	1986-08-25
K862748	Model Sc-1000 Electrocardiograph Specification	Cambridge Medical Instruments, Inc.	DPS	Class II	1986-08-25
K862526	Mini-Holter, Model 2000	Holter Recorders	DSH	Class II	1986-08-25
K862379	Corneal Modeling System	Computed Anatomy, Inc.	HJO	Class II	1986-08-25
K862244	Modifications to Cordis' Super Flow Catheters	Cordis US Corp.	DQO	Class II	1986-08-25
K862182	Amnioinfusion Catheter	Michael Reese Hospital and Medical Center	KXO	Class II	1986-08-25
K862056	[Central Venous][multi-Lumen] Catheter W/flex Tip	Arrow Intl., Inc.	DQY	Class II	1986-08-25
K861981	Electrocardiograph Lead Switching Adaptor	Vital Signs, Inc.	DRW	Class II	1986-08-25
K861900	Lifescan Evoked Potential System	Neurometrics	GWF	Class II	1986-08-25
K861538	860 Color Doppler or Colorview 860	GE Medical Systems Information Technologies, Inc.	IYO	Class II	1986-08-25
K861504	Model Fb-20 Non-Invasive Blood Pressure Monitor	Fukuda Denshi USA, Inc.	DXN	Class II	1986-08-25
K861059	Dako Ita System	Dako Corp.	DEW	Class II	1986-08-25
K861031	Wyler Sphenoidal Electrode	AD-Tech Medical Instrument Corp.	GZL	Class II	1986-08-25
K860973	Circadian Stress Test System	Circadian, Inc.	DPS	Class II	1986-08-25
K860488	Oscillomate Blood Pressure Monitor-Model 915	Cas Medical Systems, Inc.	DXN	Class II	1986-08-25
K860289	Phd-36 Physiological Signal Amplifier	Professional Health Technologies, Inc.	GWL	Class II	1986-08-25