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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3423 of 3526

510(k) clearances, page 3423 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K782102	Hycel Counter 211	Hycel, Inc.	GKL	Class II	1979-01-03
K782101	Hycel Counter 222	Hycel, Inc.	GKL	Class II	1979-01-03
K782100	Hycel Counter 333	Hycel, Inc.	GKL	Class II	1979-01-03
K782083	Vagatex	Vagatex	HIR	Class II	1979-01-03
K782067	Dilator, Mizutani Laminaria Tent	British Marketing Ent., Ltd.	HDY	Class II	1979-01-03
K782066	Exetrelut	Mcb Manufacturing Chemists, Inc.	KEA	Class I	1979-01-03
K782050	Printer, Tek Pro Tek Tally II	Tekpro	GKZ	Class II	1979-01-03
K782041	Fiax Test Kit	Idt, A Division of Whittaker M.A. Bioproducts	DHN	Class II	1979-01-03
K782007	Rotary Scaler	Star Dental Mfg. Co.	ELB	Class II	1979-01-03
K781996	Acid Reagent, Uric Single Vial	Calbiochem-Behring Corp.	CDO	Class I	1979-01-03
K781970	Cholesterol Reagent Substrate Set	Corning Medical & Scientific	JHO	Class I	1979-01-03
K781969	Blood, Hematology Reference Control	Coulter Electronics, Inc.	JPK	Class II	1979-01-03
K781968	Blood Gas System Model 168	Corning Medical & Scientific	CHL	Class II	1979-01-03
K781941	Analysis System, Prep Sample	E.I. Dupont de Nemours & Co., Inc.	DOZ	Class II	1979-01-03
K781921	Bilirubin, Dingle Valve Dpd	Boehringer Mannheim Corp.	CIG	Class II	1979-01-03
K781905	Ria Kit, Quantitope T3 Uptake	Kallestad Laboratories, Inc.	KHQ	Class II	1979-01-03
K781850	Ria, Quantimune E3	Bio-Rad	CGI	Class I	1979-01-03
K781834	Test Set, 125 I-Digoxin	Wien Laboratories, Inc.	DNL	Class II	1979-01-03
K781827	Control Set, Emit Methotrexate	Syva Co.	LAS	Class I	1979-01-03
K781784	Ast	Gilford Diagnostics	CIT	Class II	1979-01-03
K781177	Ultrasound Breast Scanning Device	Life Instrument Corp.	IYO	Class II	1979-01-03
K790031	Generator, Biotec 876 Pulse	Biomagnetic Technologies, Inc.			1979-01-02
K781871	Diffusion Option, Omni-Lab	Ohio Medical Products	CCJ	Class II	1979-01-02
K782108	Medtronic Model 546	Medtronic, Inc.	DTE	Class II	1978-12-29
K782076	Ht-110 Micromini	Health Tech	DXH	Class II	1978-12-29
K781944	Stockinette	Kimberly-Clark Corporation	KKX	Class II	1978-12-29
K781878	Light, Inside	Midwest	EAY	Class I	1978-12-29
K781794	Beta-Tec	Wampole Laboratories	JHI	Class II	1978-12-29
K782065	Laser, Photocoagulation	Cavitron Corp.	HQF	Class II	1978-12-28
K782064	Table, Examining-Two Eighty	Amsco Co.	ETF	Class I	1978-12-28
K781974	Implant Drivers and Tips	Miter, Inc.	DZJ	Class II	1978-12-28
K781882	Modulat Dental Systems	Vacudent Sales Corp.	EIA	Class I	1978-12-28
K781788	Gold, 24 Karat Casting	Williams Gold Refining Co., Inc.	EJT	Class II	1978-12-28
K782146	Pacemaker, Model Ddp Electronic Circuit	Arco Medical Products Co.	DXY	Class III	1978-12-27
K782120	Sponge System, Rosering Contain-Count	MEDLINE INDUSTRIES, LP - Northfield			1978-12-27
K782152	Valve, Ambu PEEP	Narco Air-Shields	BYE	Class II	1978-12-26
K781910	Monitor, Sensomatiii Oxygen	Biochem International, Inc.	KLK	Class II	1978-12-26
K782097	Electrode Lead Model 030-198	Telectronics, Inc.	DTD	Class II	1978-12-22
K782029	Maxi Camera 400T	General Electric Co.	IYX	Class I	1978-12-22
K782023	Microlith a Model 803	Cardiac Pacemakers, Inc.	DXY	Class III	1978-12-22
K782022	Microlith a Model 703	Cardiac Pacemakers, Inc.	DXY	Class III	1978-12-22
K780430	Lithicron F Programmable Pulse Gen	Medcor, Inc.	DXY	Class III	1978-12-22
K782074	Ventilator, Model Ava-1, Adult	Rule Medical Instruments, Inc.	CBK	Class II	1978-12-21
K782059	Transmitter, Tr-1 ECG	Burdick Corp.	DXH	Class II	1978-12-21
K781926	Ventilator, Infant Model 100	Healthdyne, Inc.	CBK	Class II	1978-12-21
K781835	Pulstron Model 100	Micro-Rel	DXY	Class III	1978-12-21
K781624	Pacing Lead Model Bus 860, Bus 890	R.E. Brown Co., Inc.	DTB	Class III	1978-12-21
K782090	Clamp, Disposable	Concord Laboratories, Inc.	HXD	Class I	1978-12-20
K782082	Catheter, Digital Positral II	C.R. Bard Inc	DQO	Class II	1978-12-20
K782060	Multiformat Film Cassette Transport	Mediscan, Inc.	IYO	Class II	1978-12-20