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 3362 of 3526

510(k) clearances, page 3362 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800420	Adt Percutaneous Non-Disp. Needle	A.D.T. Lab Industries	FCG	Class II	1980-03-25
K800419	Adt Percutaneous Transhepatic Disp. Chol	A.D.T. Lab Industries	FCG	Class II	1980-03-25
K800416	Adt Disposable Thin Needle(skinny Chiba)	A.D.T. Lab Industries	FCG	Class II	1980-03-25
K800415	Adt Menghini Type Soft Tissue Biopsy	A.D.T. Lab Industries	GAA	Class I	1980-03-25
K800413	Ferris Modified Disp. Il Sternal-Iliac	A.D.T. Lab Industries	GAA	Class I	1980-03-25
K800396	Stat Temp Model 4800	Baessler Medical Electronics,Inc.	FLL	Class II	1980-03-25
K800337	Dvt Prevention Sys. Mbe 22 Pressure U.	Med-Bio Engineering, Inc.	JOW	Class II	1980-03-25
K800327	Magnesium Reagent	Alta Diagnostics, Inc.	JGJ	Class I	1980-03-25
K800320	Cesium-137 Afterloading System /Gyn.bra.	Amersham Corp.	IWJ	Class I	1980-03-25
K800250	Hmb-200	Associated Mills, Inc.	IRO	Class I	1980-03-25
K800064	Water Jel Fire Blanket	Trilling Resources, Ltd.	FPY	Class I	1980-03-25
K800015	Axiom Vessel Loops	Axiom Medical, Inc.	KDC	Class I	1980-03-25
K792602	Susi II Pacemaker Surveillance Monitor	Ela Medical, Inc.	DTC	Class II	1980-03-25
K800571	Dahlberg #Az Behind the Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1980-03-20
K800552	Zeiss Disposable, Sterile Surgical Drape	Carl Zeiss, Inc.	KKX	Class II	1980-03-20
K800544	Corning Transphor	Corning Medical & Scientific	JHX	Class II	1980-03-20
K800529	Centrifichem Bun	Union Carbide Corp.	CDQ	Class II	1980-03-20
K800523	Monel 80&90 Ultraviolet-Visible Spec.	Varian Assoc., Inc.	JJQ	Class I	1980-03-20
K800518	Utage-Matsu-Micro-Thin Utage-Sakura,	Kopharm, Inc.	HIS	Class II	1980-03-20
K800517	Tobram E.r.a. Tm	P-L Biochemicals, Inc.	KLQ	Class II	1980-03-20
K800457	Liquid-Stat Liquid Reagent	Beckman Instruments, Inc.	CHH	Class I	1980-03-20
K800453	Photovolt Pva 4M+2 Analyzer	Photovolt Corp.	JJC	Class I	1980-03-20
K800137	Pri. Piggyback i.v. W/dual Piercing Pin	Abbott Medical	FPA	Class II	1980-03-20
K800516	Dupont Instruments Model 870 Liq. Chrom.	E.I. Dupont de Nemours & Co., Inc.	KIE	Class I	1980-03-19
K800514	Phencyclidine Direct Blood Ria Kit	Immunalysis Corporation	LCL	Unclassified	1980-03-19
K800486	Stim-Ex 201	Th Charters, Inc.	IPF	Class II	1980-03-19
K800462	Percutaneous Introducer Set	Medical Components, Inc.	DRE	Class II	1980-03-19
K800436	T3 Solid Phase Radioimmunoassay Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	CDP	Class II	1980-03-19
K800429	Tryptic Soy Broth W/c02,cysteine & 1%	Abbott Medical	JSC	Class I	1980-03-19
K800428	Tryptic Soy Broth W/cysteine and	Abbott Medical	JSC	Class I	1980-03-19
K800427	Tryptic Soy Broth W/c02,sps&1% Yeast Ext	Abbott Medical	JSC	Class I	1980-03-19
K800426	Tryptic Soy Broth(tsb) W/c02 & 1% Yeast	Abbott Medical	JSC	Class I	1980-03-19
K800385	Analyte T4-Thyroxine	Technicon Instruments Corp.	CDX	Class II	1980-03-19
K800384	Smac System, T4 Method	Technicon Instruments Corp.	KLI	Class II	1980-03-19
K800381	Refrig. Centrifuge (Drucker Model)	Coulter Electronics, Inc.	JQC	Class I	1980-03-19
K800377	Cardioplegia Delivery System	3M Health Care, Sarns	DTR	Class II	1980-03-19
K800315	Dual Mpc Charger	Black & Decker(Tm)	KIJ	Class I	1980-03-19
K800314	Power Pack	Black & Decker(Tm)	KIJ	Class I	1980-03-19
K800287	Ceph Lactam Disk	Remel Co.	JSF	Class I	1980-03-19
K800244	Behind Ear Hearing Aid Model E24c1	Oticon, Inc.	ESD	Class I	1980-03-19
K800205	Ria Phase Digoxin	Boehringer Mannheim Corp.	DPO	Class II	1980-03-19
K800204	Ria Phase Tbg	Boehringer Mannheim Corp.	CEE	Class II	1980-03-19
K800203	Ria Phase T4	Boehringer Mannheim Corp.	CDX	Class II	1980-03-19
K800180	Various Reagents for Blood Cell Analyzer	Laboratory Products, Inc.	GIF	Class I	1980-03-19
K800161	Hepcon/system Rc-10	Hemotec, Inc.	JOX	Class II	1980-03-19
K800087	Ultrasonic Flowmeter	Revvity Health Sciences, Inc.	BXP	Class I	1980-03-19
K792715	Smith's Systemic Fungal Medium	Meridian Diagnostics, Inc.	JSJ	Class I	1980-03-19
K792675	Charcoal Yeast Extract(cye) Agar	Remel Co.	JSJ	Class I	1980-03-19
K792635	Antibody to Rubella Virus	Electro-Nucleonics Laboratories, Inc.	GOK	Class II	1980-03-19
K800548	Supersil	Harry J. Bosworth Co.	ELW	Class II	1980-03-18