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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2699 of 3530

510(k) clearances, page 2699 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884042	Rocket Cervical Spatula	A & A Medical, Inc.	HHT	Class II	1988-10-07
K884041	Master-Guard	Sparco, Inc.	KCT	Class II	1988-10-07
K883988	Non-Rebreathing Tee Piece (Nrtp)	Dhd Medical Products Div. Diemolding Corp.	CBP	Class II	1988-10-07
K883963	Raney and Leroy-Raney Scalp Clip	New England Surgical Instrument Corp.	HBO	Class II	1988-10-07
K883876	Williams-Fritts Pleural Biopsy Needle	E.G. Dick & Assoc.	GDM	Class I	1988-10-07
K883546	Teec (Transesophageal Echocardiography) Transducer	Advanced Technology Laboratories, Inc.	IYO	Class II	1988-10-07
K883520	0.5 T Compact Magnet for Its Vista Mr 2055 Hp Syst	Philips North America LLC	LNH	Class II	1988-10-07
K883516	Diasonics Mt/p Imaging System	Diasonics, Inc.	LNH	Class II	1988-10-07
K883483	Autoflow Part Number Pr3241-420 Pressure Regulator	Autoflow Products, Co.	CAN	Class I	1988-10-07
K883101	Dvs (Option 01)	O.M.I. Oncology Microsystems, Inc.	IYE	Class II	1988-10-07
K882590	Viaderm	Applied Biomedical Sciences	KGN	Unclassified	1988-10-07
K881739	Lenz Clenzer	Lens Care, Inc.	LYL	Class II	1988-10-07
K873674	Sdu-700 Phased Array Sector and Linear Scanner	Shimadzu Corp.	JOP	Class II	1988-10-07
K884139	Acci-Guard(tm) Regular and Pediatric Holder	Medical Safety Products, Inc.	FMI	Class II	1988-10-06
K884064	Bard Multi-Tac ECG Monitoring Electrode	C.R. Bard Inc	DRX	Class II	1988-10-06
K884031	Fbs, Eq., or Fetal Bovine Serum Equivalent	Regency Biotech	KIT	Class I	1988-10-06
K884011	Snap N' Stain Iron Stain	Scientific Device Laboratory, Inc.	GGH	Class I	1988-10-06
K883936	Ortho* Toxoplasma-M Antibody Elisa Test	Ortho Diagnostic Systems, Inc.	LGD	Class II	1988-10-06
K883777	Clearview Hcg	Unipath, Ltd.	JHI	Class II	1988-10-06
K883683	Hemoglobin	Tech-Co, Inc.	GJZ	Class II	1988-10-06
K883639	Modified Hcg Irma Kit	Pacific Biotech, Inc.	JHI	Class II	1988-10-06
K883584	First Medic Mode 610	First Medical Devices Corp.	MKJ	Class III	1988-10-06
K883571	Histo-Check Parasitic Control Slides	Val Tech Diagnostics, Inc.	LJG	Class I	1988-10-06
K883570	Histo-Check Fungal Control Slides	Val Tech Diagnostics, Inc.	LJG	Class I	1988-10-06
K883569	Histo-Check Gram Negative Slides	Val Tech Diagnostics, Inc.	LJG	Class I	1988-10-06
K883568	Histo-Check Acid Fast Slides	Val Tech Diagnostics, Inc.	LJG	Class I	1988-10-06
K883567	Histo-Check Legionella Control Slides	Val Tech Diagnostics, Inc.	LJG	Class I	1988-10-06
K883523	Triad-Ep, Pushbutton, Cable Input Type, W/pulse	Cardiotronics, Inc.	DRO	Class II	1988-10-06
K883511	Albabond E	Degussa Dental, Inc.	EJS	Class II	1988-10-06
K883388	Dentrek Bridge Bars	Dale T. Dupuis	EHO	Class I	1988-10-06
K883386	Chloride	Tech-Co, Inc.	CHJ	Class II	1988-10-06
K883352	Fluorescein Conjugated Anti-Chlamydia Mono Anti	Whittaker Bioproducts, Inc.	LJP	Class I	1988-10-06
K883306	Binas Luteinizing Hormone Irma Test Kit	Binax, Inc.	JIT	Class II	1988-10-06
K883305	Binax Fsh Irma Test Kit, Immunoradiometric Assay	Binax, Inc.	CGJ	Class I	1988-10-06
K883297	Hewlett-Packard Modles 78354A/78352 Pulse Oximeter	Hewlett-Packard Co.	DQA	Class II	1988-10-06
K883147	Trace Elements Serum Toxicology Control	Utak Laboratories Inc	JJY	Class I	1988-10-06
K883051	Usci Soft-Tip Angiographic Catheter	C.R. Bard Inc	DQO	Class II	1988-10-06
K883015	Polysafe Implant. Pacing Leads W/trabeculok Tip	Cardiac Control Systems, Inc.	DTB	Class III	1988-10-06
K882756	Lantor Cube Sterilizer Test Pack	Lantor Group	JOJ	Class II	1988-10-06
K882728	Amerlite Endocrinology Control Sera Lan.4190	Amersham Corp.	JJY	Class I	1988-10-06
K882588	Blue Dot(tm) Test for Pregnancy	V-Tech, Inc.	LCX	Class II	1988-10-06
K882475	Amerlite Rubella Antibody Assay, Lan.0200/2200	Amersham Corp.	LFX	Class II	1988-10-06
K882380	Scimed Model Sm-C/vr Cardiotomy/venous Reservoir	Scimed Life Systems, Inc.	DTN	Class II	1988-10-06
K882327	Pacer Sensing Analyzer (Psa 100)	Oscor Medical Corp.	DTC	Class II	1988-10-06
K882199	Clotest, Campylobacter Pylori Urease Enzyme Test	Auspharm Intl., Ltd.	LYR	Class I	1988-10-06
K881983	Howmedica Precision Osteolock Femoral Component	Howmedica Corp.	LWJ	Class II	1988-10-06
K881380	B. Fragtex	American Biomedical Products, Inc.	JSP	Class I	1988-10-06
K880674	Micromedic Crackpot Ria Kit	Icn Micromedic Systems	KLN	Class II	1988-10-06
K880599	Pocket Manometer	Abbott Medical	DXN	Class II	1988-10-06
K883965	Probe, Imaging, Ultrasonic, Mechanical Sector	Teknar, Inc.	IYO	Class II	1988-10-05