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 2925 of 3529

510(k) clearances, page 2925 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854822	Lds PEEP Valve	Life Design Systems, Inc.	BYE	Class II	1986-02-24
K854747	Travoneb Model # Tone 1	Travomed, Inc.	BTI	Class II	1986-02-24
K854726	Medi-Wipes United Antiseptic Skin Prep	Pfizer Inc	EXB	Class I	1986-02-24
K854719	Lung Care (Specimen Transport & Storage Container)	Xsirius Scientific, Inc.	LIO	Class I	1986-02-24
K854678	Erma Pc-602 Pc-603 Blood Cell Counter	Future Impex Corp.	GKL	Class II	1986-02-24
K854677	Erma Pc-604 Blood Cell Counter	Future Impex Corp.	GKL	Class II	1986-02-24
K854514	Ambi-24 Ph/pressure Monitor	Biosearch Medical Products, Inc.	FFT	Class I	1986-02-24
K854438	The Answer Hearing Aid	Electone, Inc.	ESD	Class I	1986-02-24
K853739	Sonolayer Sal-55A/55as	Toshiba Medical Systems	IYO	Class II	1986-02-24
K853471	Ccs Implantable Maestro 106/206/210 Cardiac Pacema	Cardiac Control Systems, Inc.	DXY	Class III	1986-02-24
K853400	Ccs Implantable Maestro Series 200 Cardiac Pacemak	Cardiac Control Systems, Inc.	DXY	Class III	1986-02-24
K853101	Vascuter External Reinforce Triaxial Prostheses	Cobe Laboratories, Inc.	DSY	Class II	1986-02-24
K860583	Dale Head Band Anesthesia Circuit Tube Holder 1315	Dale Medical Products, Inc.	JAY	Class I	1986-02-21
K860556	Series 7050 Capnograph	Marquette Electronics, Inc.	CCK	Class II	1986-02-21
K860555	Cprcoach Voice Prompter & CPR Prompter Rescue Aid	Auralogic			1986-02-21
K860516	Lsp Minilator	Life Support Products, Inc.	BXY	Class I	1986-02-21
K860454	Basicam S Counter Balance Camera	Siemens Gammasonics, Inc.	IXY	Class I	1986-02-21
K860326	Tubular Ortho. Stockinette W/antimicrobial Agent	DeRoyal Industries, Inc.	KKX	Class II	1986-02-21
K860257	Direct Bilirubin	Horiba Instruments Incorporated	CIG	Class II	1986-02-21
K860135	Easy-Test Urea (Bun) Reagent	Em Diagnostic Systems, Inc.	CDQ	Class II	1986-02-21
K860034	Para-Pak Macro-Con	Meridian Diagnostics, Inc.	LKS	Class I	1986-02-21
K855208	Bunn Lite Oxygen Concentrator	The John Bunn Co.	CAW	Class II	1986-02-21
K855108	Rascal Anesthesia Respiratory Gas Analyzor	Biomaterials International, Inc.	JJQ	Class I	1986-02-21
K855093	Medilas 2 Nd:yag Laser Surgery System	Endo Lase, Inc.	HHR	Class II	1986-02-21
K854965	In Line Valve Catalog No. 2000A	Rao Medical Devices, Inc.	FPA	Class II	1986-02-21
K854889	Flex-I-Grasp	Euro-Med Intl.	HRX	Class II	1986-02-21
K854763	Cerapearl	Kyocera International, Inc.	EIH	Class II	1986-02-21
K854609	Mevamatic 3	Siemens Medical Laboratories, Inc.	JAD	Class II	1986-02-21
K854416	Tdx Transferrin Diagnostic Kit	Abbott Medical	DDG	Class II	1986-02-21
K853992	Valley Forge Scien-TENS Unit & Access. Lead Wire &	Valley Forge Scientific Corp.	GZJ	Class II	1986-02-21
K853991	Hofmann Knee	Intermedics Orthopedics	JWH	Class II	1986-02-21
K853903	Endo-Lase Cd40 CO2 for Gynecology	Endo Lase, Inc.	HHR	Class II	1986-02-21
K853876	Endo-Lse Cd-100 CO2 Laser for Gynecology	Endo Lase, Inc.	HHR	Class II	1986-02-21
K853443	Alveo-Diffusion Test	Erich Jaeger, Inc.	BZC	Class II	1986-02-21
K853240	Meridian Ultrasound Imaging System	Johnson & Johnson Professionals, Inc.	JOP	Class II	1986-02-21
K852655	Combiscope	Instrument Technology, Inc.	KNG	Class II	1986-02-21
K860510	Neonate Percussor	Ballard Medical Products	BYI	Class II	1986-02-20
K860321	Lysocolor	Cytocolor, Inc.	LED	Class I	1986-02-20
K860320	Granulocolor	Cytocolor, Inc.	LED	Class I	1986-02-20
K860319	Megacolor	Cytocolor, Inc.	LED	Class I	1986-02-20
K860317	Neutrocolor	Cytocolor, Inc.	LED	Class I	1986-02-20
K860316	Panoptikon	Cytocolor, Inc.	LED	Class I	1986-02-20
K860195	Precept Trimethoprim/sulfamethoxazole	Austin Biological Laboratories	JWY	Class II	1986-02-20
K860194	Austin Enteric System	Austin Biological Laboratories	JSE	Class I	1986-02-20
K855172	Kwi (Tm) G-Co/two	Micro-Bio-Logics	JSK	Class I	1986-02-20
K854977	Fiber Mesh	Pulpdent Corp. of America	DZE	Class II	1986-02-20
K854943	Omknee System, Porous Coated	Orthomet, Inc.			1986-02-20
K854742	Oticon, Citec Custom Made Hearing Aid Canal Type	Oticon, Inc.	ESD	Class I	1986-02-20
K854679	Photic-100 Spectrophotometer	Future Impex Corp.	JJQ	Class I	1986-02-20
K854606	Sonolayer S, Ssh-65A	Toshiba Medical Systems	DXK	Class II	1986-02-20