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 2026-10-12, 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 3311 of 3528

510(k) clearances, page 3311 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K810040	Acridine Orange Stain	BD Becton Dickinson Vacutainer Systems Preanalytic	IDC	Class I	1981-02-12
K810015	Multihi-Temp Cautery	Medical Products Development, Inc.	HAM	Class II	1981-02-12
K810014	Replacable Battery Hi-Temp Cautery	Medical Products Development, Inc.	HAM	Class II	1981-02-12
K803304	Acridine Orange Stain	Remel Co.	IDC	Class I	1981-02-12
K803250	Tassaway	Plastic Applications, Inc.	HHE	Class II	1981-02-12
K803106	Aginsky Nail	Cintor Orthopaedic Div.	HSB	Class II	1981-02-12
K803066	Disposable Bag Mask Adejunct	T. S. Enterprises, Inc.	BTM	Class II	1981-02-12
K803055	Electrosurgical Tip Cleaner & Holder	Devon Industries, Inc.	GEI	Class II	1981-02-12
K802485	Searle Vascular Loops	G.D. Searle and Co.	KDC	Class I	1981-02-12
K802357	Telemetry Pacemaker Monitor	Intermedics, Inc.	DRG	Class II	1981-02-12
K801584	Multi-Programmable Pacemaker & Progrmr.	Medtronic, Inc.	DXY	Class III	1981-02-12
K810261	Eurochima Urea Nitrogen	Volu Sol Medical Industries	CDL	Class II	1981-02-10
K810253	Sodium & Potassium Test Kit	Mallinckrodt Critical Care	JGM	Class II	1981-02-10
K810235	Acetaminophen/salicylate Control	Clin Tech Diagnostics Corp.	DIF	Class I	1981-02-10
K810232	Leeco P.a.p. - Quant Diagnostic Kit	Leeco Diagnostics, Inc.	JFH	Class II	1981-02-10
K810231	Code Im 2050 Amerlex Free T4 Ria Kit	Amersham Corp.	CEC	Class II	1981-02-10
K810228	Sorbothane	Hamilton Kent	KNP	Class I	1981-02-10
K810224	Armstrong Spinal Appliance	Howmedica Corp.	KWP	Class II	1981-02-10
K810213	Dac-Cel Tsh	Burroughs Wellcome Co.	JLW	Class II	1981-02-10
K810212	Dac-Cel T3 Uptake	Burroughs Wellcome Co.	KHQ	Class II	1981-02-10
K810211	T3 Ria Kit	E. R. Squibb & Sons, Inc.	CDP	Class II	1981-02-10
K810210	Magic-Touch	Sci-Pharm, Inc.	DYH	Class II	1981-02-10
K810203	Model Am 722	Applied Medical Technologies	JFP	Class II	1981-02-10
K810157	Moi-Stir	Kingswood Laboratories, Inc.	LFD	Unclassified	1981-02-10
K810135	Model Am 721 Electrolyte Analyzer	Abbott Diagnostics	JGS	Class II	1981-02-10
K810117	Halogen Headlight System	Colmed, Ltd.	EBA	Class I	1981-02-10
K803127	Howmedica Knee Brush	Howmedica Corp.	LXH	Class I	1981-02-10
K803126	Exeter Total Hip System	Howmedica Corp.	JDI	Class II	1981-02-10
K801805	Metronidazole Discs	G.D. Searle and Co.	JWY	Class II	1981-02-10
K810267	Femoral Canal Brush	Richard'S Medical Equip., Inc.	LXH	Class I	1981-02-09
K810264	Disposable Pillow	Anago, Inc.	KME	Class I	1981-02-09
K810229	Sceptor System Automated Model 216	BD Becton Dickinson Vacutainer Systems Preanalytic	JTC	Class I	1981-02-09
K810226	Sle Anti-N-DNA Latex Test	Icl Scientific	DHC	Class II	1981-02-09
K810221	Scrippsera Theumatoid Factor Refer. Cntl	Scripps-Miles, Inc.	DHR	Class II	1981-02-09
K810216	Argyle Rob-Nels	Sherwood Medical Co.	KOD	Class II	1981-02-09
K810205	Mecron Cancellous Cannulated Bone Screws	Serrano Intl.	HWC	Class II	1981-02-09
K810180	Williams Oesophageal Varices Inject Tube	Keymed, Inc.	FED	Class II	1981-02-09
K810153	Ventilatory Effort Monitor	Medicon Co., Ltd.	FLS	Class II	1981-02-09
K810141	Scrippsystem Rheumatoid Factor Latex Kit	Scripps-Miles, Inc.	DHR	Class II	1981-02-09
K810125	Inertial Extensilizer Chiro. Adj. Table	The Inertial Corp.	INQ	Class I	1981-02-09
K810119	Control Serums for Nontreponemal Test	Hillside Acres, Inc.	GMP	Class II	1981-02-09
K810081	Scrippsera Ana Reference Control Sera	Scripps-Miles, Inc.	DHN	Class II	1981-02-09
K810056	Immunology Control Serum	Icl Scientific	DEW	Class II	1981-02-09
K803196	Flexible Pin S Shaped Intramed. System	Howmedica Corp.	HSB	Class II	1981-02-09
K802590	Direct Fluorescent Antibody Kit/herpes	Bartels & Stout, Inc.	GQL	Class II	1981-02-09
K802526	Test Kit for Detection of Herpes Simplex	Bartels & Stout, Inc.	LGC	Class II	1981-02-09
K802295	Poly Flex Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1981-02-09
K810192	Endab Cortisol Kit	IMMUNOTECH s.r.o.	CGR	Class II	1981-02-06
K810126	Curity Curad Bandages	The Kendal Co.	KGX	Class I	1981-02-06
K810023	Hydrophilic Coated Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic	BSY	Class I	1981-02-06