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 3065 of 3528

510(k) clearances, page 3065 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K842488	Samson 1000 Anesthesia Circuit	J. H. Emerson Co.	CAI	Class I	1984-07-06
K842487	Samson's Newborn Lung Inflator 340-1000	J. H. Emerson Co.	BTM	Class II	1984-07-06
K842472	Dryden Inflatable Mask	Dryden Corp.	BSJ	Class I	1984-07-06
K842464	Tracheal Tube/stethoscope	Mallinckrodt Critical Care	BTR	Class II	1984-07-06
K842456	Jet Ventilation Adaptor	Abbott Medical			1984-07-06
K842415	All-Hands Tracheostomy Care Set 0101	All-Hands Medical Supply, Inc.	BTO	Class II	1984-07-06
K842258	Renatron	Renal Systems, Inc.	LIF	Class II	1984-07-06
K842211	Ultra Chem Enzymatic Triglyceride	Em Diagnostic Systems, Inc.	CDT	Class I	1984-07-06
K842136	Sterile Pan Set	Medi-Plast Intl., Inc.	FRG	Class II	1984-07-06
K842135	Hi-Lo Floor Standing Exam. Light	Good-Lite Co.	KZF	Class I	1984-07-06
K842134	Somas Coomasie Blue Total Protein Assay	Somas Medical Industries, Inc.	JGQ	Class II	1984-07-06
K842081	Cook Pacemaker Corp. 115 Unipolar Cardi	Cook Pacemaker Corp.	DXY	Class III	1984-07-06
K842015	Sawyer First Aid Kit	Saffeta, Inc.	KYP	Class I	1984-07-06
K842012	Umi Curved Chemonucleolysis Needle	Universal Medical Instrument Corp.	FMI	Class II	1984-07-06
K841931	Dispo. Aes Dispos. Syringe W/needle	Hirsch Chemie, Ltd.	FMF	Class II	1984-07-06
K841907	Bactigen - N.menninigitidis Test	Armkel, LLC	GTJ	Class II	1984-07-06
K841906	Maxicamera 400 Ac	General Electric Co.	IYX	Class I	1984-07-06
K841884	Kodak Ektachem Control	Eastman Kodak Company	JJY	Class I	1984-07-06
K841831	Cannu-Skreen-Preliminary	Biochemical Diagnostic, Inc.	DKE	Class II	1984-07-06
K841810	Mark5 Arterial Blood Gas Kit	Martell Medical Products, Inc.	FMF	Class II	1984-07-06
K841780	Clinical Electronic Thermometer	Fidelity Medical, Inc.	FLL	Class II	1984-07-06
K841772	Heparin Cap, Injection Cap Male Luer-	Linton Biomed Corp.	FPA	Class II	1984-07-06
K841756	Liebel-Flarsheim Acs 1000 Chest X-Ray	Syvron Corp.	KPR	Class II	1984-07-06
K841742	Non-Coring Needle	Creative Care Systems, Inc.	FMI	Class II	1984-07-06
K841605	Bp Trauma Air Pants	Bp Medical Systems, Inc.	LHX	Class II	1984-07-06
K841575	Sentech's Ulab 1000 Clinical Chem.	Sen Tech Medical Corp.	CEM	Class II	1984-07-06
K841513	Scanlan Atraum Instrument Jaw Cover	Scanlan Intl., Inc.			1984-07-06
K841431	Radiographic Film Processor M-30Cr &	The Allen Products Co.	IXX	Class II	1984-07-06
K841403	Hemo-Ro Water Purification Sys	EMD Millipore Corporation	FIP	Class II	1984-07-06
K841354	Curette	Treace Medical, Inc.	JYG	Class I	1984-07-06
K841353	Causse Sponge Boat	Treace Medical, Inc.	ETB	Class II	1984-07-06
K841289	Rectal Irrigation Tube	Hdc Corp.	KNT	Class II	1984-07-06
K841233	Pulse Generator 678L	Siemens Elema AB	DXY	Class III	1984-07-06
K841202	Dacomed Rigiscan System	Dacomed Corp.	LIL	Unclassified	1984-07-06
K841169	Curity Rig Foley Cath Tray	The Kendal Co.	KNX	Class II	1984-07-06
K841152	Hospal Biospal Scu/cavh Kit	Hospal Medical Corp.	KDI	Class II	1984-07-06
K841043	Behring Elisa Processor M	Behring Diagnostics, Inc.	JQW	Class I	1984-07-06
K840875	Multivariate Digital Cardiograph	Clinical Microsystems Intl.	DQK	Class II	1984-07-06
K840846	Sterile Hichman/broviac Injection Cap	Evermed, Inc.	LJS	Class II	1984-07-06
K842480	Sure & Natural Maxi-Shield	Johnson & Johnson Professionals, Inc.	HHD	Class I	1984-07-03
K842129	Lyfo-Disk Microorganisms	Micro-Bio-Logics	JTR	Class I	1984-07-03
K842112	Tischler Cervical Biopsy Punch Forceps	J. Sklar Mfg. Co., Inc.	HFB	Class I	1984-07-03
K842095	Epidural Trays	Concord Laboratories, Inc.	CAZ	Class II	1984-07-03
K842086	Spottest Lactophenol Cotton Blue Stain	Difco Laboratories, Inc.	JTO	Class I	1984-07-03
K842016	Dispos. Poly Aprons	Abco Dealers, Inc.	LDQ		1984-07-03
K841859	Secura Set	Diatek, Inc.	FPA	Class II	1984-07-03
K841682	Uterine Injector 4.0Mm	Humi Corp.	HES	Class II	1984-07-03
K841672	Fall-Safe Vest	Fsm Corp.	KMI	Class I	1984-07-03
K841671	Fall-Safe Monitor	Fsm Corp.	KMI	Class I	1984-07-03
K841647	Neuromedics Ultrastim 650-01	Intermedics, Inc.	IPF	Class II	1984-07-03