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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3143 of 3528

510(k) clearances, page 3143 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831462	Api Uniscept Plus 140 Inoculator	Analytical Products, Inc.	JTC	Class I	1983-08-12
K831443	Paceline Patient Transmitter Model 324	Pacesetter Systems	DXH	Class II	1983-08-12
K831396	P-S Medical Csf-Lumboperitoneal Shunt	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1983-08-12
K831350	Ivflo-Hp & Ivfil-Hp Filter	Tri-Med, Inc.	FPB	Class II	1983-08-12
K831315	Trilex	Tri-Med, Inc.	FPB	Class II	1983-08-12
K831284	Gauze Bandage	Pac-Kit Safety Equipment Co.	NAB	Class I	1983-08-12
K831283	Triangle Bandage Sterile	Pac-Kit Safety Equipment Co.	NAD	Class I	1983-08-12
K831282	Bandage Compress	Pac-Kit Safety Equipment Co.	NAB	Class I	1983-08-12
K831281	Gauze Compress	Pac-Kit Safety Equipment Co.	NAB	Class I	1983-08-12
K831130	Dispos. Abodominal Retracting Pad	Product Development Corp.	DWF	Class II	1983-08-12
K831129	Hearco C	Hear Co., Inc.	ESD	Class I	1983-08-12
K831116	Invac W/various Models	Pmt, Inc.	GCX	Class II	1983-08-12
K831115	Epcom Ems-320 Remote Monitorscope	Epcom Medical Systems, Inc.	HGM	Class II	1983-08-12
K831114	Epcom Ems-330 Freedom I Teledop Obstet	Epcom Medical Systems, Inc.	HGM	Class II	1983-08-12
K831113	Epcom Ems-310 Intrapartum Monitor	Epcom Medical Systems, Inc.	HGM	Class II	1983-08-12
K831086	Ceiling Mounted Support	Amsco Co.	FQO	Class I	1983-08-12
K831048	Tufcote Epilation Probe	Serapis Medical Electronics, Co.	KCW	Class I	1983-08-12
K830992	Xcel Model Xe-1	Electrocaine Medical System	GZJ	Class II	1983-08-12
K830914	External Valve Function Block	Honeywell, Inc.	DRQ	Class II	1983-08-12
K830870	Polychaco Indirect Hemagglutination	Parasitic Disease Consultants	GMM	Class II	1983-08-12
K830756	Gonochek Panel	E-Y Laboratories, Inc.	JTO	Class I	1983-08-12
K830754	Blood Pressure Monitoring Kits,walrus	Medical Parameters, Inc.	DXT	Class II	1983-08-12
K830716	Cardio-Esophascope	Abbott Medical	BZT	Class II	1983-08-12
K830292	Bioelectrical Impedance Analyzer #101	Rjl Systems, Inc.	DSB	Class II	1983-08-12
K823225	Geliperm Granules	Geistlich Pharma AG	FRO	Unclassified	1983-08-12
K822073	Geliperm Dry	Hamel, Park, Mccabe & Saunders	FRO	Unclassified	1983-08-12
K822058	Geliperm Transparent Gel-Film Dressing	Hamel, Park, Mccabe & Saunders	FRO	Unclassified	1983-08-12
K832323	Edslab Pressure Gauge	American Edwards Laboratories	MAV	Class II	1983-08-11
K832097	Phenobartial Assay Use on Cobas-Bio	Syva Co.	DLZ	Class II	1983-08-11
K832094	Bilirubin Calibrators & Control	Gilford Diagnostics	JIT	Class II	1983-08-11
K832071	Total CO2 Reagent Set	American Research Products Co.	CIE	Class II	1983-08-11
K832046	Seralyzer Multicomponent Calibrators	Miles Laboratories, Inc.	JIX	Class II	1983-08-11
K832031	Anti-N DNA Antibody Test Kit	Breit Laboratories, Inc.	KTL	Class II	1983-08-11
K832007	Pentax Fg-34Ja Gastrofiberscope	Pentax Precision Instrument Corp.	FDS	Class II	1983-08-11
K832004	Wako Cpk Test	FUJIFILM Healthcare Americas Corporation	JHY	Class II	1983-08-11
K831978	Emit Serum Tricyclic Antidepressent	Syva Co.	LFG	Class II	1983-08-11
K831966	Cardioplegia Reservoir-#500926	American Bentley	DTN	Class II	1983-08-11
K831964	Cms 2000 Series Tpn Kits	Currie Medical Specialties, Inc.	FMC	Class I	1983-08-11
K831961	Immunodiffusion Test Human Antithrombin	Kent Laboratories, Inc.	JBQ	Class II	1983-08-11
K831955	Hr 100T	Thought Technology Ltd.	JOM	Class II	1983-08-11
K831924	Antibody to Respiratory Syncytial Virus	Electro-Nucleonics Laboratories, Inc.	LKT	Class I	1983-08-11
K831857	Surgitek Percutaneous Arnegrade Silitek	Medical Engineering Corp.	FAD	Class II	1983-08-11
K831852	Fetal Monitor #115	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1983-08-11
K831824	Dental Electronic/s.b.r Trading Bu Hand	Silverman'S	EAY	Class I	1983-08-11
K831775	Ucg-Beta Slide Monoclonal	Armkel, LLC	JHJ	Class II	1983-08-11
K831746	Pisces #3487 Epidural Lead for Spinal	Medtronic, Inc.	GZB	Class II	1983-08-11
K831726	Eye Muscle Sleeves	S. Jackson, Inc.	FTM	Class II	1983-08-11
K831698	Disposable Pressure Transducer#14004195	Norton Performance Plastics Corp.	DRS	Class II	1983-08-11
K831689	Empty Dialysate Container	Delmed, Inc.	FKK	Class I	1983-08-11
K831641	Reader Microelisa System	bioMerieux, Inc.	LIB	Class I	1983-08-11