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 2835 of 3529

510(k) clearances, page 2835 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K870269	Electrosurgical Meniscus Cutter (Emc) Mod. Amc-100	American Bentley	GEI	Class II	1987-03-09
K870063	CO2 Laser Bronchoscope Set	Tti Medical	EOQ	Class II	1987-03-09
K864956	Dynex III Transcutaneous Electrical Nerve Stimula.	La Jolla Technology, Inc.	GZJ	Class II	1987-03-09
K864644	Phoenix-C Anesthesia Machine	American Anesthesia, Inc.	BSZ	Class II	1987-03-09
K864533	Hood Bifurcated T-Tube	Hood Laboratories	BTR	Class II	1987-03-09
K864308	Bauman Cpr/respirator	General Medical Products, Inc.	BTM	Class II	1987-03-09
K863618	Bone Mineral Densitometry Option B7918aa	General Electric Co.	KGI	Class II	1987-03-09
K862928	Amukin-50% for Capd Y-Set	Amuchina Intl., Inc.	FKX	Class II	1987-03-09
K862643	Radiation Oncology Computer Sys Treatment Planning	Pacific Physics, Inc.			1987-03-09
K870762	Ear Applicator, Catalog No. 2229	Treace Medical, Inc.	KXF	Class I	1987-03-06
K870757	Otological Metric Scale/gauge	Treace Medical, Inc.			1987-03-06
K870628	Microbond Composite Kit for Ceramic Bonding System	Chem-E-Dent	EBF	Class II	1987-03-06
K870616	Glucose Oxidase Reagent	Intersect Systems, Inc.	CGA	Class II	1987-03-06
K870553	Easy-Test Magnesium (Mg) Item No. 16Xxx	Em Diagnostic Systems, Inc.	JGJ	Class I	1987-03-06
K870526	Super Urine Analyzer System	Kyoto Daiichi Kagaku Co., Ltd.	KQO	Class I	1987-03-06
K870500	Major Quality Glucose and Ketones Urine Test	American Diagnostic Corp.	JIL	Class II	1987-03-06
K870461	Easy-Test Creatine Kinase (Ck) Number: 16614	Em Diagnostic Systems, Inc.	CGS	Class II	1987-03-06
K870401	Wako(tm) Autokit Ldh	FUJIFILM Healthcare Americas Corporation	CFJ	Class II	1987-03-06
K870399	Selverstone Clamp Salibi Clamp	Cerenovus, Inc.	HCE	Class II	1987-03-06
K870382	Drv Disp Resuscit 3000/Bag Adapt 3010 & 3011	Nova-Ventrx	CBP	Class II	1987-03-06
K870253	Inspiron(r) Breath for Life Emerg. Resuscitator	Intertech Resources, Inc.	CBP	Class II	1987-03-06
K870205	Rotax-II Bi-Plane Circular Arm	B C Medical, Ltd.			1987-03-06
K870170	Easy-Test Calcium (Ca), Item No. 67528/93	Em Diagnostic Systems, Inc.	CIC	Class II	1987-03-06
K870138	1160 Simple Isolation Valve & 1161 Filtered Valve	Hudson Oxygen Therapy Sales Co.	CBP	Class II	1987-03-06
K870094	Bunn Model 530 Aspirator	The John Bunn Co.	BTA	Class II	1987-03-06
K870086	Alanine Aminotransferase (Alt)/(gpt)	Catachem, Inc.	CKA	Class I	1987-03-06
K870077	Aspartate Aminotransferase (Ast)/(got)	Catachem, Inc.	CIT	Class II	1987-03-06
K865036	Ciba Corning Model 278 Ph/blood Gas System	Ciba Corning Diagnostics Corp.	CHL	Class II	1987-03-06
K864889	Omni-Trak	Invivo Research Labs, Inc.	DSB	Class II	1987-03-06
K864886	Respigraph-Respisomnograph-Respicentral	Nims/Respitrace Corp.	BZK	Class II	1987-03-06
K864836	L.a.p. Spirometer	Timeter Instrument Corp.	BTY	Class II	1987-03-06
K864632	P.c.a. Modular Knee System	Howmedica Corp.	JWH	Class II	1987-03-06
K864507	V-Pace(tm) Transluminal Ventricular/ Model Sp5540	Spectramed, LLC	LDF	Class II	1987-03-06
K863853	Eazy Covers	Superior Medical Products	JAA	Class II	1987-03-06
K870574	Cosmedtech General Aspirator	Cosmedtech, Inc.	HHI	Class II	1987-03-05
K870417	Rct-1, Rct-2, Rct-3 Arthrogram Tray	North Coast Medi-Tek	FSM	Class I	1987-03-05
K870347	Aztreonam 30 Mcg Sensitivity Disks	Difco Laboratories, Inc.	JTN	Class II	1987-03-05
K870046	Double Puncture CO2 Laser Laparoscopy Set	Tti Medical	HHR	Class II	1987-03-05
K864378	CO2 Laser Micromanipulator	Transamerican Technologies Intl.	HHR	Class II	1987-03-05
K864140	Kidney Perfusion Machine	Advanced Equipment Development, Inc.	KDN	Class II	1987-03-05
K870758	Small Mastoid Retractor	Treace Medical, Inc.	KAL	Class I	1987-03-04
K870681	Huntleigh Beta II Hm85	Huntleigh Technology, Inc.	FNM	Class II	1987-03-04
K870597	D. Farinae Allergen Disc	Incstar Corp.	DHB	Class II	1987-03-04
K870571	Emds Urea Nitrogen (Bun) Testpacks Item #67654/95	Em Diagnostic Systems, Inc.	CDQ	Class II	1987-03-04
K870560	Cosmedtech Cannula	Cosmedtech, Inc.	HHI	Class II	1987-03-04
K870550	Teflon Uterine Sound	Cook Ob/Gyn	HHM	Class I	1987-03-04
K870501	The Equalizer Airway Device	Sleep Renewal, Inc.	LQZ	Class II	1987-03-04
K870408	Easy-Test Triglyceride (Trig) Number 16608	Em Diagnostic Systems, Inc.	CDT	Class I	1987-03-04
K870407	Easy-Test Cholesterol(chol) Number 16607	Em Diagnostic Systems, Inc.	CHH	Class I	1987-03-04
K865070	Chiro-Stim	Diversified Chiropractic Systems	IPF	Class II	1987-03-04