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 2026-10-15, 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 3171 of 3528

510(k) clearances, page 3171 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K830660	Sterile Surgical Drapes	Phoenix Glove Co.	KKX	Class II	1983-03-17
K830659	Clearium, Mounting Medium	Surgipath Medical Industries, Inc.	KEP	Class I	1983-03-17
K830649	Sutter Cpm 2000	Sutter Biomedical, Inc.	BXB	Class I	1983-03-17
K830645	Bleeding Time Device Disposable	American Dade	JCA	Class II	1983-03-17
K830583	Neutral Buffered Formalin 10%	Surgipath Medical Industries, Inc.	IFP	Class I	1983-03-17
K830582	Millonig's Modified Phosphate Buffered	Surgipath Medical Industries, Inc.	IFP	Class I	1983-03-17
K830576	Lymphangiography Set	Vertex Medical Corp.	DQO	Class II	1983-03-17
K830572	Clean-Flush	Burron Medical Products, Inc.	KYZ	Class I	1983-03-17
K830552	Luer Lock Temperature Sensor	Mon-A-Therm, Inc.	FLL	Class II	1983-03-17
K830542	Hemaquik II Staining Solution #55961	Accra Laboratories, Inc.	IAF	Class I	1983-03-17
K830540	Rennco Model Ls Lift Seal Heat Sealer	Rennco, Inc.	FRG	Class II	1983-03-17
K830539	Intravascular Catheter Set	Lab-A-Cath Corp.	FOZ	Class II	1983-03-17
K830531	Mono Screening Test	Tago, Inc.	KTN	Class II	1983-03-17
K830511	Zanlex, Zan-Tex & Zandex	Winn Hirsch & Assoc.	GDY	Class I	1983-03-17
K830499	Esa Electrosurgical Arthroscopy Genera	Concept, Inc.	HRX	Class II	1983-03-17
K830491	Johnson & Johnson Opaque Color Modifi	Johnson & Johnson Professionals, Inc.	EBE	Class II	1983-03-17
K830457	Pacing Lead #PMA F 860	Ela Medical, Inc.	DTB	Class III	1983-03-17
K830442	Prisma-Fine	Dentsply Intl.	EBF	Class II	1983-03-17
K830438	Mcdlsck 126 Double Lumen Subclavian-Fem	Medcomp	LFJ	Class II	1983-03-17
K830437	Chs	Dms Laboratories	JSC	Class I	1983-03-17
K830404	Rad Valve	Khi, Inc.	BTL	Class II	1983-03-17
K830401	Unilith Pulse Generator Vvi #7542	Ela Medical, Inc.	DXY	Class III	1983-03-17
K830387	Microdapt Dental Restorative Bonding	Johnson & Johnson Professionals, Inc.	KLE	Class II	1983-03-17
K830382	Command Ultra II	Cardiac Pacemakers, Inc.	DXY	Class III	1983-03-17
K830380	Microdapt Dental Restorative	Johnson & Johnson Professionals, Inc.	EBF	Class II	1983-03-17
K830359	Sterile Catherization Procedure Trays	Welcon, Inc.	KOD	Class II	1983-03-17
K830357	Radioimmunoassay Immunoglobulins D.e	Clinetics Corp.	DGC	Class II	1983-03-17
K830343	Container W/priming Solution	American Hospital Supply	KDP	Class II	1983-03-17
K830337	Mark III Oxygen Walker Sys-Low Press	Union Carbide Corp.	BYJ	Class II	1983-03-17
K830330	Savett Alcohol Prep	Cederroth, Inc. USA	LKB	Unclassified	1983-03-17
K830306	Heartrate Plus ECG Cardule #1918	Spacelabs, Inc.	DSI	Class II	1983-03-17
K830260	Floret Vaginal Packing/tampons	Ritmed, Inc.	GDY	Class I	1983-03-17
K830231	Asahi Hollow Fiber Kidneys, Am-Series	Advocacy International, Ltd.	KOC	Class II	1983-03-17
K830221	Bedside N.p.t. 9900 - Printer 9800	Browne Medical, Inc.	LIL	Unclassified	1983-03-17
K830183	Asahi Hollow Fiber Kidneys Nr Series	Advocacy International, Ltd.	KOC	Class II	1983-03-17
K830120	Improved Arthroscope	Markoptic	HRX	Class II	1983-03-17
K823909	T-Tube Vent Tube	Treace Medical, Inc.	ETD	Class II	1983-03-17
K823852	Chesebrough-Pond's Multilayer Elastic	Chesebrough-Pond'S U.S.A. Co.	NAD	Class I	1983-03-17
K823828	Theracard 400	Siemens Medical Solutions USA, Inc.	LDD	Class II	1983-03-17
K823827	Amp 80/2 Outflow Monitor Modification	American Medical Products LLC	FKX	Class II	1983-03-17
K823463	Right Time Rhythm Clock	P.K. Morgan Instruments, Inc.	LHD	Unclassified	1983-03-17
K823424	Meniscectomy Tray #9715	Concept, Inc.	HAW	Class II	1983-03-17
K823059	Dosimetry Release of Radiation Steril.	Zimmer GmbH			1983-03-17
K822342	Ortho Rubella Elisa Test System	Ortho Diagnostic Systems, Inc.	LFX	Class II	1983-03-17
K830523	Catheter Connection W/integral Injectate	Gould, Inc.	DQO	Class II	1983-03-16
K830464	Pacemaker Electrode Perm. & Temp	Daig Corp.	DTB	Class III	1983-03-16
K823831	Medtronic Models 59401 5941	Medtronic, Inc.	DXY	Class III	1983-03-16
K830247	Split Colon Stiffening Tube	Keymed, Inc.	FED	Class II	1983-03-15
K837102	Model 2100 Fetal Monitor	Huntleigh Group, Ltd.			1983-03-14
K837110	Model 4100 Microsurgical CO2 Laser System	Bio Quantum Technologies, Inc.			1983-03-11