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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2501 of 3531

510(k) clearances, page 2501 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K900720	Mortara Instrument Model X-Scribe (Treadmill Included)	Mortara Instrument, Inc.	DSI	Class II	1990-11-05
K896729	Nelaton-, Female - or Tiemann Catheter	Unoplast A/S	KOD	Class II	1990-11-05
K904733	Qualicheck 3	Radiometer America, Inc	JJS	Class I	1990-11-02
K904675	Qbc System Mchc	BD Becton Dickinson Vacutainer Systems Preanalytic	JPJ	Class II	1990-11-02
K904666	Amerlite Tsh-60 Assay Product Code: Lan. 0008/2008	Amersham Corp.	JLW	Class II	1990-11-02
K904503	Seracon Cr Reference	Bhp Diagnostix, Inc.	JJX	Class I	1990-11-02
K904479	Surgical Inst.:1030,1010,1011,1012,1013,1014,1015	Percutaneous Technologies	HRX	Class II	1990-11-02
K904278	Holder, Dental Bur, Aluminum	Maverick Surgical, Inc.	EJI	Class II	1990-11-02
K904160	Cytosmear Brush	Brooke Intl.	HHI	Class II	1990-11-02
K904094	C.a.t.,sinterline,natural Arch,microtwin,biotorque	Lancer Orthodontics, Inc.	EJF	Class I	1990-11-02
K904089	Perma Mesh	Lancer Orthodontics, Inc.	EJF	Class I	1990-11-02
K903763	Computed Tomography X-Ray System	General Electric Co.	JAK	Class II	1990-11-02
K903649	Bradley Tenaculum Holder	Marlo Surgical Technology	KDC	Class I	1990-11-02
K903532	Unna-Sleeve(tm)	Aci Medical, LLC	LLK	Class II	1990-11-02
K903382	Allergy Control Covers	Allergy Control Products, Inc.	FMW	Class I	1990-11-02
K903238	Afga Video Imager, Various Models	Enhanced Imaging Technologies, Inc.	LMC	Class II	1990-11-02
K902956	Latex Examination Gloves	Pacificlink Export Industries Private, Ltd.	LYY	Class I	1990-11-02
K902700	Heveashield Examination Gloves	Pacificlink Export	LYY	Class I	1990-11-02
K900371	Mentor Modified Malleable Penile Prostheses	Mentor	FAE	Class II	1990-11-02
K896732	Unometer 500	Unoplast A/S	EXR	Class II	1990-11-02
K895435	Fresenius as 104 Cell Separator	Fresenius USA, Inc.	LKN	Unclassified	1990-11-02
K904673	Oticaon Bte Model E34p	Oticon, Inc.	ESD	Class I	1990-11-01
K904635	Microzyme Thc Enzyme Immunoassay Test Kit	IMMUNOTECH s.r.o.	LDJ	Class II	1990-11-01
K904497	Cromatest Rheumatoid Diagnostic/crp Latex Test	Biotrax, Inc.	DCN	Class II	1990-11-01
K904437	Argenco 19	Argen Precious Metals, Inc.	EJT	Class II	1990-11-01
K904289	Pertac Universal Bond	Espe GmbH (US)	KLE	Class II	1990-11-01
K904204	Thrombelastograph	Haemoscope Corp.	GKP	Class II	1990-11-01
K904163	Clinical Blood Gas Mixtures	Norco, Inc.	LCH	Class I	1990-11-01
K904141	Tdm Plus Xl Enhanced Liq Drug Control I,ii,iii	Medical Analysis Systems, Inc.	JJY	Class I	1990-11-01
K902958	Tst Control Integrator for Steam Autoclave	Board of Directors, Albert Browne, Ltd.	JOJ	Class II	1990-11-01
K902837	Amicon Diafilter 30 Hemoconcentrator	Amicon, Inc.	KDI	Class II	1990-11-01
K902741	Vascumed Ez Y-Connector	Vascumed Systems	DTL	Class II	1990-11-01
K904826	Tko Telescoping Lithotomy Stirrup	D.L. Nelson and Assoc., Inc.	FWZ	Class I	1990-10-31
K904757	Oxygen, Air, Vacuum & Nitrous-Oxide Couplers	Medical Fittings, Inc.	BYX	Class I	1990-10-31
K904702	Medi Fitt/oxequip Oxygen/air Male Quick Connects	Medical Fittings, Inc.	BYX	Class I	1990-10-31
K904701	Medi Fitt/ohmeda Oxy/air/vac&nit-Oxi Male Qk Conn	Medical Fittings, Inc.	BYX	Class I	1990-10-31
K904544	Acoustic Appraiser Cd-2 Audiometer/master Hear.aid	Qualitone	EWO	Class II	1990-10-31
K904467	Argilite 3	Argen Precious Metals, Inc.	EIT	Class II	1990-10-31
K904343	Argenco 22	Argen Precious Metals, Inc.	EJT	Class II	1990-10-31
K904273	Magnum Plus Latex Condoms with Spermicidal Lub.	Carter Products	LTZ	Class II	1990-10-31
K904218	Suction System	Axiom Medical, Inc.	GEA	Class I	1990-10-31
K904185	Sensatrace	Ludlow Corp., Technical Papers Division	DRX	Class II	1990-10-31
K904085	Ella Breast Form	MEDLINE INDUSTRIES, LP - Northfield	KCZ	Class I	1990-10-31
K903918	Model 1850 Electrode	Medtronic, Inc.	DRX	Class II	1990-10-31
K903816	Urine Meter Foley Tray with Temperature Sensor	Respiratory Support Products, Inc.	EZK	Class II	1990-10-31
K903750	Islam Sternal Puncture Needle, Cat #Ag-598-Oo-E	Downs Surgical, Ltd.	GDM	Class I	1990-10-31
K903749	Islam Sternal Puncture Needle, Cat #Ag-596-00-U	Downs Surgical, Ltd.	GDM	Class I	1990-10-31
K903748	Islam Sternal Puncture Needle, Cat # Af-594-00-V	Downs Surgical, Ltd.	GDM	Class I	1990-10-31
K903747	Islam Sternal Puncture Needle, Cat # Ag-592-00-U	Downs Surgical, Ltd.	GDM	Class I	1990-10-31
K903410	Bio-Medicus Cannula Introducer	Bio Medicus, Inc.	DYB	Class II	1990-10-31