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 2873 of 3529

510(k) clearances, page 2873 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863483	Cassette Embosseer	Surgipath Medical Industries, Inc.	IDZ	Class I	1986-09-16
K863426	Amresco Flow Pac Total Iron Reagent Set #1241	American Research Products Co.	JMO	Class I	1986-09-16
K863423	Code-a-Well Series 1-1000 and Series 1-1100	Plastic Injectors, Inc.	JTC	Class I	1986-09-16
K863326	Bone Marrow Tray	Packaging Technologies, Inc.	GAA	Class I	1986-09-16
K863253	Alt/gpt Procedure	Data Medical Associates, Inc.	CKA	Class I	1986-09-16
K863202	Cholinesterase (Ptc) Reagent	Sigma Diagnostics, Inc.	DIH	Class I	1986-09-16
K863099	Abbott Testpack (Tm) Acute Hep a Control Kit	Abbott Medical	JJK	Class I	1986-09-16
K863004	Emds(tm) Albumin Testpacks, #67652/95	Em Diagnostic Systems, Inc.	CJW	Class II	1986-09-16
K863003	Emds(tm) Calcium Testpacks, #67687/95	Em Diagnostic Systems, Inc.	CIC	Class II	1986-09-16
K862914	Fekal Check Parasitology Control Slide	Trend Scientific, Inc.	JTR	Class I	1986-09-16
K862901	Ventrescreen II Pollens Enzyme Immunoassay	Ventrex Laboratories, Inc.	DHB	Class II	1986-09-16
K862813	Fsh Maiaclone Immunoradiometric Assay Kit	Serono Diagnostics, Inc.	CGJ	Class I	1986-09-16
K862592	Phoenix System Seven.	Nicolet Biomedical Instruments	EWO	Class II	1986-09-16
K862475	Respirastick Enzyme Immunoassay Test	Orion Diagnostica, Inc.	GTY	Class I	1986-09-16
K862429	Abbott Rsv Eia	Abbott Medical	GQG	Class I	1986-09-16
K862371	Hemoglobin A1c by Column Test (Micro A1c)	Bio-Rad	LCP	Class II	1986-09-16
K862156	Asserachrom D-Di Kit	American Bioproducts Co.	DAP	Class II	1986-09-16
K861449	Vacuum Blood Collecting System (Neo-Tube)	Exel Intl.	GIM	Class II	1986-09-16
K861420	Quantimetrix Drug Free Human Urine Control	Quantimetrix Corp.	JJY	Class I	1986-09-16
K861354	Right-Day Ovulation Home Test	Leeco Diagnostics, Inc.	CEP	Class I	1986-09-16
K863383	Facial Massager, Battery Powered	General Physiotherapy, Inc.	ISA	Class I	1986-09-15
K863343	Superfixation(tm)	Orthopaedic Device Corp.	KTT	Class II	1986-09-15
K863283	Care + Plus Suture Removal Tray	Welmed Systems, Inc.			1986-09-15
K863263	Albumin Procedure	Data Medical Associates, Inc.	CIX	Class II	1986-09-15
K863216	Neis Nzy	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1986-09-15
K863199	Cards(tm) Hcg-Urine	Pacific Biotech, Inc.	JHI	Class II	1986-09-15
K863191	Bactec 13A Medium (7H13)	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1986-09-15
K863127	Testpack Acute Hcg Uringe Controls	Abbott Medical	JJW	Class I	1986-09-15
K863126	Testpack Acute Hcg Serum Controls	Abbott Medical	JJX	Class I	1986-09-15
K863098	Meadow Fescue Allergen Disc	Immuno Nuclear Corp.	DHB	Class II	1986-09-15
K863032	Abbott Testpack (Tm) Hcg Serum	Abbott Medical	JHI	Class II	1986-09-15
K863025	Sero-Stat R II Staphylococcus Test	Scott Laboratories, Inc.	LHT	Class I	1986-09-15
K862999	Ultrascan Clinical Analyzer	Specialty Medical Industries, Inc.	JJQ	Class I	1986-09-15
K862963	Therapeutic Drug Monitoring Control Set	American Monitor Corp.	JJY	Class I	1986-09-15
K862908	Akerscan Colorimetric Analyzer	Akers Medical Technologies	JJQ	Class I	1986-09-15
K862810	Companion 2500 Portable Volume Ventilator	Medtronic, Inc.	CBK	Class II	1986-09-15
K862749	Ls9000 Suction Biopsy Needle	Engineering, Inc.	GDM	Class I	1986-09-15
K862618	Skintact Ag Electrodes	Leon H. Lang Co.	DRX	Class II	1986-09-15
K862423	Model 8-B CO2 Laser for General & Plastic Surgery	Directed Energy, Inc.	GEX	Class II	1986-09-15
K861808	Vascutek Vascular Prostheses, Extra Soft/low Woven	Cobe Laboratories, Inc.	DSY	Class II	1986-09-15
K863396	Concept Intravision Arthroscope System	Concept, Inc.	HRX	Class II	1986-09-12
K863360	Neomed Non Gel-R Total Adhesive Conduct. Electrode	Richards Medical Co., Inc.	GEI	Class II	1986-09-12
K863336	Cordipak Angiography Tray	Angi-Pak Corp.			1986-09-12
K863241	Laser Assisted Surgical Laparoscopy Kits	Lifestream Int'L, Inc.			1986-09-12
K862836	Stockert-Shiley Caps and Caps Dual Pressure Module	Shiley, Inc.	DXS	Class II	1986-09-12
K862688	Ohmeda 5420 Volume Monitor	GE Healthcare	BZK	Class II	1986-09-12
K862687	Ohmeda 5410 Volume Monitor	GE Healthcare	BZK	Class II	1986-09-12
K862551	Funs-10, Funs-11	Reichert-Jung, Inc.	FGB	Class II	1986-09-12
K862536	Model 1010 Ambulatory Ph Monitoring System	Oxford Medilog, Inc.	FFT	Class I	1986-09-12
K862472	Quartz Rods Titanium Rods	Quali-Med, Inc.	GEX	Class II	1986-09-12