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 2026-10-21, 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 3003 of 3529

510(k) clearances, page 3003 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844680	Cybertens	Pori Associates, Inc.	GZJ	Class II	1985-04-05
K843712	Audit Tm V	Axonics, Inc.	GWF	Class II	1985-04-05
K851081	Implantable Program-Cardiac Pulse Gen-Optima Mp II	Telectronics, Inc.	DXY	Class III	1985-04-04
K851075	Norelco Digital Model 970 Thermometer	Philips Park	FLL	Class II	1985-04-04
K851010	Norelco Digital Model 987 Thermometer	Philips Park	FLL	Class II	1985-04-04
K850757	Tandem Sets i.v.	Acacia, Inc.	LHI	Class II	1985-04-04
K850710	Travenol Flo-Gard 500 IV Monitor	Travenol Laboratories, S.A.	FLN	Class II	1985-04-04
K850252	Qmplantable Program. Cardiac Pulse Gen. W/telemetr	Telectronics, Inc.	DXY	Class III	1985-04-04
K850244	Clinical Electronic Thermometers	Sheridan Catheter Corp.	FLL	Class II	1985-04-04
K850082	Hand Held Goniometer	Chattanooga Group, Inc.	KQW	Class I	1985-04-04
K850064	Wheelchair, Mechanical	Comaco, Inc.	IOR	Class I	1985-04-04
K850044	Treadmill E-17	Del Mar Avionics	IOL	Class I	1985-04-04
K850027	Meditech Euroscanner M250	Stuart Medical, Inc.	JAK	Class II	1985-04-04
K844988	Ethox Neonatal Blood Pressure Cuff-Sterile/dispos.	Ethox Corp.	DXQ	Class II	1985-04-04
K844816	Matrix 101 Negative Galvanic Generator	Prn Medical	GEI	Class II	1985-04-04
K844215	Kontron Minimon 7134 Patient Monitor	Kontron Instruments, Inc.	DRT	Class II	1985-04-04
K844214	Compartment Syndrome Pressure Monitor Sys	Stryker Corp.	LXC	Unclassified	1985-04-04
K851113	Randall Kidney Stone Forceps 817-144 Pcs. Full Cur	The Huxley Instrument Corp.	KOA	Class I	1985-04-03
K851112	Randall Kidney Stone Forceps 817-144 Pcs. Quarter	The Huxley Instrument Corp.	KOA	Class I	1985-04-03
K851111	Randall Kidney Stone Forceps 817-84 Pcs. Half Curv	The Huxley Instrument Corp.	KOA	Class I	1985-04-03
K851032	Cobas Fp Reagents for Digoxin & Cobas Fp Digoxin C	Roche Diagnostic Systems, Inc.	KXT	Class II	1985-04-03
K851009	Infusion Sleeve - Ophthalmic	Medical Instrument Development Laboratories, Inc.	HQC	Class II	1985-04-03
K850954	Ureteral Dilator & Ureteral Stone Dislodger	American Edwards Laboratories	FFL	Class II	1985-04-03
K850866	Toray Industries Filtryzer Hollow Fiber Kidney B1l	Erika, Inc.	KDI	Class II	1985-04-03
K850865	Toray Industries Filtryzer Hollow Fiber Kidney B1-	Erika, Inc.	FJI	Class II	1985-04-03
K850748	I-L Test, Direct Bilirubin Set	Allied Instrumentation Laboratory	CIG	Class II	1985-04-03
K850580	Diagnostic Ultrasound Sys Model Uls1000	Elscint, Inc.	IYO	Class II	1985-04-03
K850578	Phacoemulsification Tip	Ultramed, Inc.	HQC	Class II	1985-04-03
K850538	Bed Sentry, Model 50U	Metatech Corp.	KPN	Class II	1985-04-03
K850271	Angiomedic's Catheter-Diagnostic Intravascular	Angiomedics, Inc.	DQO	Class II	1985-04-03
K850254	Parathyroid Hormone Radioimmunoassay Kit	Cambridge Medical Technology	CEW	Class II	1985-04-03
K845046	Pul,monary Artery Vent Catheter	Dlp, Inc.	DWF	Class II	1985-04-03
K845045	Venous Return Catheter Ss-1	Dlp, Inc.	DWF	Class II	1985-04-03
K844866	Nytone Enuretic Alarm Bedwetting Device	Nytone Medical	KPN	Class II	1985-04-03
K844636	Sentry Signal Enuresis Alarm System	Conklin Technology, Inc.	KPN	Class II	1985-04-03
K844464	Programmable Patient Simulator	Ramford Labs	DSI	Class II	1985-04-03
K843908	Abbott Tdt Eia	Abbott Medical	CIG	Class II	1985-04-03
K843062	Tbm-Reagent for T,b Cell & Monocytes	BD Becton Dickinson Vacutainer Systems Preanalytic	LIZ	Class II	1985-04-03
K842277	Dimertest Latex	Mabco, Inc.	GHH	Class II	1985-04-03
K820267	Intermedics Polyflex Pacing Lead #480-01	Intermedics, Inc.	DTB	Class III	1985-04-03
K813136	Model 492-01 Pacemaker Lead	Intermedics, Inc.	DTB	Class III	1985-04-03
K813135	Model 486-01 Pacemaker Lead	Intermedics, Inc.	DTB	Class III	1985-04-03
K802294	Poly Flex Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-04-03
K850920	Emit D.a.u. Propoxyphene Assay	Syva Co.	JXN	Class II	1985-04-02
K850800	Dropstirs - Plastic Disposable Pipet	Berwick Medical Products, Inc.	JQW	Class I	1985-04-02
K850779	Model 4000 Nd:yag Laser for Genitourinary Applicat	Cooper Lasersonics, Inc.	GEX	Class II	1985-04-02
K850747	Tri-Med Model 105 Special Airway Adaptor	Tri-Med, Inc.	CCK	Class II	1985-04-02
K850746	Tri-Med Model 126 Sample Line W/extended Life Nafi	Tri-Med, Inc.	CCK	Class II	1985-04-02
K850745	Tri-Med Model 112 Moisture Trap	Tri-Med, Inc.	CCK	Class II	1985-04-02
K850730	Model Serum Hcg Assay	Monoclonal Antibodies, Inc.	JHI	Class II	1985-04-02