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 2560 of 3530

510(k) clearances, page 2560 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K897193	Opus T4 Test System	Pb Diagnostic Systems, Inc.	KLI	Class II	1990-03-19
K897176	Systemate(tm) Total Bilirubin Catalog No. 654Xx	Em Diagnostic Systems, Inc.	CIG	Class II	1990-03-19
K897105	Chemo-Shield	Vision Plastics, Inc.	FMF	Class II	1990-03-19
K896967	Hts 820 Cardiac Monitor	Life Sensing Instrument Company, Inc.	DSI	Class II	1990-03-19
K895535	Paceview	Micromedical, Inc.	KRE	Class II	1990-03-19
K895534	Biolog	Micromedical, Inc.	DRT	Class II	1990-03-19
K894904	Kinamed Ceramic Ath Total Hip - 28Mm Ball	Kinamed Inc	LZO	Class II	1990-03-19
K893740	Lipidirect Low Density Lipoprotein Cholesterol Tes	Reference Diagnostics, Inc.	MRR	Class I	1990-03-19
K893557	Adam (Acoustical Device for Anatomical Monitoring)	Medical Monitors, Inc.	DQD	Class II	1990-03-19
K901069	Computerized Functional Testing Gait System	Computerized Functional Testing Corp.	KHX	Class I	1990-03-16
K900979	Gas Sampling Nasal Cannula	Gibeck, Inc.	CCK	Class II	1990-03-16
K900787	Nasal E.t. Tape	B & B Medical Technologies, Inc.	CBH	Class I	1990-03-16
K900228	H.e.a.r.t. Nebulizer	B & B Medical Technologies, Inc.	CAF	Class II	1990-03-16
K900003	System Ten Model 100 Surgical System	Advanced Osseous Technologies	JDX	Class II	1990-03-16
K897100	Centurion Vaginal Speculum	Centurion Medical Products, LP	HIC	Class II	1990-03-16
K897057	Thayer Semi-Rigid Condensate Collection System	Thayer Medical Corportation	BYH	Class I	1990-03-16
K897051	Miller Percutaneous Angiographic/scopic Irri. Cath	Cathlab Corp.	DQO	Class II	1990-03-16
K897049	Gibson Endolymphatic Shunt	Hood Laboratories	ESZ	Class II	1990-03-16
K897041	Hemaquet(tm) and Hemaflex(tm) Introducers	C.R. Bard Inc	DYB	Class II	1990-03-16
K897039	Sarns Miniprime Cardioplegia Set W/conducer(tm)	3M Company	DTR	Class II	1990-03-16
K897023	Oversight Program for in-Office Assembly, Hrng Aid	Audina Hearing Instrument, Inc	LRB	Class I	1990-03-16
K897022	Picso Cannula, Catalog Code 94315	Dlp, Inc.	DWF	Class II	1990-03-16
K897005	Blom-Singer(r) Silicone Laryngectomy Tube	Freudenberg Medical, LLC	JOH	Class II	1990-03-16
K897003	Olympus Hysteroresectoscope	Olympus Corp.	HIH	Class II	1990-03-16
K895963	Modified Star Calc	Infrasonics Corp.	BZC	Class II	1990-03-16
K894096	Stat-Trach(tm) Ventilation Catheter	Statron Corp.	BTO	Class II	1990-03-16
K901026	Mj Percussor(tm)	Merced Medical, Inc.	BYI	Class II	1990-03-15
K900821	Autosceptor-Gram-Positive Mic Panel Reading	BD Becton Dickinson Vacutainer Systems Preanalytic	LRG	Class II	1990-03-15
K900763	Enzymun Test(r) Fsh	Boehringer Mannheim Corp.	CGJ	Class I	1990-03-15
K900754	Respirex 2	Diemolding Corp.	BWF	Class II	1990-03-15
K900594	Anesthesia Breathing Circuit	Inhalation Plastics, Inc.	CAI	Class I	1990-03-15
K900574	Abiomed Body Lead Analyzer Model 200/20	Abiomed, Inc.	JAO	Class II	1990-03-15
K900400	Orthokrome* Antithrombin	Ortho Diagnostic Systems, Inc.	JBQ	Class II	1990-03-15
K900399	Orthokrome* Plasminogen	Ortho Diagnostic Systems, Inc.	GGP	Class II	1990-03-15
K900398	Orthokrome* Protein C	Ortho Diagnostic Systems, Inc.	GGP	Class II	1990-03-15
K900397	Orthokrome* Antiplasmin	Ortho Diagnostic Systems, Inc.	GGP	Class II	1990-03-15
K900396	Orthokrome* Heparin	Ortho Diagnostic Systems, Inc.	KFF	Class II	1990-03-15
K900395	Orthokrome* Factor VIII	Ortho Diagnostic Systems, Inc.	GGP	Class II	1990-03-15
K900309	Venoject II Blood Collection Tubes	Terumo Medical Corp.	JKA	Class II	1990-03-15
K900104	Tcpm II Tourniquet Cuff Pressure Monitor	Electromedics, Inc.	KCY	Class I	1990-03-15
K900065	Non-Electric Biopsy Forceps	Esco Precision, Inc.	FCL	Class I	1990-03-15
K900022	Bj Star All Silicone Foley Balloon Catheter	B.J. Star, Inc.	KOD	Class II	1990-03-15
K900015	Non-Electric Biopsy Forceps	Esco Precision, Inc.	FCL	Class I	1990-03-15
K897175	Olympus Direct Bilirubin	Em Diagnostic Systems, Inc.	CIG	Class II	1990-03-15
K897144	Thyroxin(t4) Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	KLI	Class II	1990-03-15
K897096	Model 404A i.v. Infusion Pump Analyzer	Dynatech/Nevada, Inc.	FRN	Class II	1990-03-15
K896174	Protein S Antigen Rocket Eid Kit, Cat. No. 5359	Helena Laboratories, Corp.	GGP	Class II	1990-03-15
K895982	Widex Hearing Aid Model Es 10 Asp T	Widex Hearing Aid Co., Inc.	ESD	Class I	1990-03-15
K895981	Widex Hearing Aid Models Es9t and Es9h	Widex Hearing Aid Co., Inc.	ESD	Class I	1990-03-15
K895195	Chemo-Touch	Medical Resources, Ltd.	LZC	Class I	1990-03-15