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 2026-10-19, 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 3041 of 3529

510(k) clearances, page 3041 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843730	Shiley Dispos. Decannulation Plug W/sw/	Shiley, Inc.	BTO	Class II	1984-10-19
K843729	Shiley Dispos. Cannula Fenestrated Low	Shiley, Inc.	BTO	Class II	1984-10-19
K843714	Double Contoured Cuff Tracheal Tube	GE Healthcare	BTR	Class II	1984-10-19
K843631	Miniset Vein Infusion Sets	Travenol Laboratories, S.A.	FPA	Class II	1984-10-19
K843591	Intercept	Vital Signs, Inc.	KDP	Class II	1984-10-19
K843405	Molicare	Paul Hartmann AG	EYQ	Class I	1984-10-19
K843404	Molinea Incontinent Pad	Paul Hartmann AG	EYQ	Class I	1984-10-19
K843403	Molinea Panty	Paul Hartmann AG	EYQ	Class I	1984-10-19
K843396	Ls-260G Monitor/recorder & Defibillator	Life Science Instrumentation, Inc.	LDD	Class II	1984-10-19
K843274	Modular Volumetric Infusion Pump Sys	American Edwards Laboratories	FRN	Class II	1984-10-19
K843224	Uropump Model 1711	Life-Tech Intl., Inc.	FFG	Class II	1984-10-19
K842568	Radionuclide Infusion System	Squibb Diagnostics	FRN	Class II	1984-10-19
K842547	Wet-Stop	Palco Laboratories, Inc.	KPN	Class II	1984-10-19
K842460	Vf-Pd-120	Valpey-Fisher Corp.	JOP	Class II	1984-10-19
K842170	Empty Solution Transfer Container	The Healthcare Group Laboratories, Inc.	KPE	Class II	1984-10-19
K841959	Cardio Metric Custom Perfusion Tubing	Sterile Design, Inc.	DWE	Class II	1984-10-19
K841263	Cardioscan - Tm Being Applied for	Interspec, Inc.	DXK	Class II	1984-10-19
K844012	Ohmeda Anesthesia Record Keeper	GE Healthcare	BSZ	Class II	1984-10-18
K843932	Vapor-Phase Humidifier Sys-Advanced	Inspiron Corp.	BTT	Class II	1984-10-18
K843726	Namic Adb Angiographic Dump Bag	North American Instrument Corp.	DQO	Class II	1984-10-18
K843719	Single Wall Introducer Needle	Ocean Medical Products, Ltd.	DYB	Class II	1984-10-18
K843632	Hollow Fiber Dialyzer	Travenol Laboratories, S.A.	KOC	Class II	1984-10-18
K843542	Shiley Coronary Cardioplegia Adaptor	Shiley, Inc.	DWF	Class II	1984-10-18
K843538	Po 2 Lytrode	Polystan C/O Vitalcor, Inc.	DRY	Class II	1984-10-18
K843527	Orthomite 111 Adhesive	Rocky Mountain Orthodontics, Inc.	DYH	Class II	1984-10-18
K843504	Amer. Bentley Hemofilter Holder Hfh-1	American Bentley	FKI	Class II	1984-10-18
K843500	French 7 Tri-Access Compact Central Vein	Cardio-Vascular Innovations, Inc.	DYB	Class II	1984-10-18
K843481	Pharma-Plast Connecting Tube Type Urin-	Zimmar Consulting, Ltd.	KNX	Class II	1984-10-18
K843444	Argyle Silicone Left Ventricular and	Sherwood Medical Co.	DWF	Class II	1984-10-18
K843411	Thermal Dilution Catheter	Andover Medical, Inc.	DYG	Class II	1984-10-18
K843409	Flow-Directed Thermodilution Cath	Andover Medical, Inc.	DYG	Class II	1984-10-18
K843287	Arrhythmia Central Occ-7101	Nihon Kohden America Inc	DSI	Class II	1984-10-18
K843229	Lifepak 200	Physio Control, Inc.	LDD	Class II	1984-10-18
K843145	Two Component Rtv Vinyl Silicone Mater	Crown Delta Corp.	ELW	Class II	1984-10-18
K843014	Fresenius Haemodialysis A2008	Seratronics, Inc.	KDI	Class II	1984-10-18
K842994	Ema Freegenol Dental Cement	Int'L Corp.	EMA	Class II	1984-10-18
K842885	Extended Life Capd Solution Transfer	Travenol Laboratories, S.A.	FKX	Class II	1984-10-18
K842829	High Pressure, 1 & 3 Way Sterile Dispos	North American Instrument Corp.	DTL	Class II	1984-10-18
K842810	Infrared Coagulator	Endo Lase, Inc.	KNS	Class II	1984-10-18
K842624	Lifepak 8	Physio Control, Inc.	LDD	Class II	1984-10-18
K842616	Spacelabs Alpha Pc Patient Computer	Spacelabs, Inc.	DSI	Class II	1984-10-18
K842481	American Edwards Mini-Flex Angioscope	American Edwards Laboratories	LYK	Class II	1984-10-18
K841802	Electrode Catheter, Orthogonal Type	Webster Laboratories, Inc.	LDF	Class II	1984-10-18
K841585	Amer. Bentley Continu-Blood Processor-	American Bentley	KDI	Class II	1984-10-18
K841416	Pediatric Diag. Criteria Option 5600C	Hewlett-Packard Co.	DSI	Class II	1984-10-18
K843947	Doument Tm Linearity Test Standards	Casco Standards	JIX	Class II	1984-10-17
K843864	Ultraclone Ecl-01-1400 Cell Line	Earl-Clay Laboratories, Inc.	KIT	Class I	1984-10-17
K843863	Ultraclone Ecl-01-1300 Cell Line	Earl-Clay Laboratories, Inc.	KIT	Class I	1984-10-17
K843862	Ultraclone Ecl-01-900 Cell Line	Earl-Clay Laboratories, Inc.	KIT	Class I	1984-10-17
K843837	Medtronic 5984-5984Lp-5985	Medtronic, Inc.	DXY	Class III	1984-10-17