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 2026-10-21, 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 2985 of 3529

510(k) clearances, page 2985 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851974	V. Mueller Vital Skin Stapler	American V. Mueller	GDT	Class I	1985-06-11
K851795	41-250 to 41-282 Various Nasal Cutting Forceps	Artiberia	KAE	Class I	1985-06-11
K851794	41-180 to 41-246 Various Nasal Forceps	Artiberia	KAE	Class I	1985-06-11
K851775	19-790 to 19-1042 Dressing/sponge Forceps	Artiberia	KAE	Class I	1985-06-11
K851763	13-320,13-330 Two Types Nazal Scissors-Heyman,beck	Artiberia	KBD	Class I	1985-06-11
K851716	865/1 to 875/3 Various Types of Dental Bone Files	Artiberia	EMI	Class I	1985-06-11
K851715	830/4 to 848/7 Various Types Chisels	Artiberia	EML	Class I	1985-06-11
K851714	820/1 to 820/51 Various Types Bone Rongeurs	Artiberia	EMM	Class I	1985-06-11
K851713	680/1 to 785/2 Various Types & Sizes of Root Eleva	Artiberia	EMJ	Class I	1985-06-11
K851712	600/203 to 650/74Xn Various Types of Dent Extracti	Artiberia	EMG	Class I	1985-06-11
K851711	600/7 to 600/288 Various Types of Amer. Pattern De	Artiberia	EMG	Class I	1985-06-11
K851710	586 to 596 Various Types Dental Root Splinter Forc	Artiberia	EMH	Class I	1985-06-11
K851709	560 to 577 Various Types of Forceps for Children	Artiberia	EMG	Class I	1985-06-11
K851489	Arterial-Venous Compression Dressing	Medi-Plast Intl., Inc.			1985-06-11
K851419	Multicor Gamma 402 Series Pacer	Cordis US Corp.	DXY	Class III	1985-06-11
K851418	Omni-Atricor Model 308A	Cordis US Corp.	DXY	Class III	1985-06-11
K851417	Multicor Gamma Models 336/337	Cordis US Corp.	DXY	Class III	1985-06-11
K851416	Stanicor Gamma 333B/334a	Cordis US Corp.	DXY	Class III	1985-06-11
K851284	Radial Immuno-Diffusion Plates Iga, Igd, Igg & Igm	Cooper Biomedical, Inc.	CZP	Class II	1985-06-11
K844834	Machida Flexible Nasopharyngo-Laryngoscope Fns-1	Machida America, Inc.	EOQ	Class II	1985-06-11
K844815	Cordis Electrophysiology Stimulator	Cordis US Corp.	JOQ	Class II	1985-06-11
K843273	Dispos. Pressure Kit 1295K Series	Hewlett-Packard Co.	DRS	Class II	1985-06-11
K833047	Dosimetric Release of Rad. Tubing Pac	American Bentley	DWF	Class II	1985-06-11
K852246	Ysi Model 791/799 Disp Temp Probe & 7900 Ex Cable	Yellow Springs Instrument Co., Inc.	FLL	Class II	1985-06-10
K852161	Serum Iron/vibc Reagent Set	Livonia Diagnostics, Inc.	JIY	Class I	1985-06-10
K852131	Bun(endpoint) Reagent	Sigma Diagnostics, Inc.	CDQ	Class II	1985-06-10
K852130	Glucose(trinder) Reagent	Sigma Diagnostics, Inc.	CGA	Class II	1985-06-10
K852117	Cyto-Tek Centrifuge	Miles Laboratories, Inc.	IFB	Class I	1985-06-10
K852045	Sed-Fix Concentrate	Surgipath Medical Industries, Inc.	IER	Class I	1985-06-10
K852013	Gentamicin Kit(fpia)	Windsor Laboratories, Inc.	LCQ	Class II	1985-06-10
K852006	Tp Biuret Reagent	Alpkem Corp.	CEK	Class II	1985-06-10
K852001	Amy Reagent	Alpkem Corp.	JFJ	Class II	1985-06-10
K851999	G-Gt Reagent	Alpkem Corp.	JQB	Class I	1985-06-10
K851933	Clinical Chemistry Analytical System	Allied Instrumentation Laboratory	JJF	Class I	1985-06-10
K851691	Willcogen Meningitidis Kit Zl25	Wellcome Diagnostics	GTJ	Class II	1985-06-10
K851413	Epilator 8500	Lois Yee Cosmetics, Inc.	KCX	Class I	1985-06-10
K851402	Leveen Inflator Disposable Inflation Syringe	Medi-Tech, Inc.	DXT	Class II	1985-06-10
K850937	Urea	Dilab, Inc.	CDW	Class II	1985-06-10
K850935	Chloride	Dilab, Inc.	CHJ	Class II	1985-06-10
K850930	Glucose	Dilab, Inc.	CGE	Class II	1985-06-10
K850929	Calcium	Dilab, Inc.	CIC	Class II	1985-06-10
K844896	Del Mar Avionics 8300 Sector Imager Sys	Del Mar Avionics	DXK	Class II	1985-06-10
K852278	Acme(brand) Low-Profile Wheelchair Scale, 17400	Acme Medical Scale Co.	FRW	Class I	1985-06-07
K852259	Ivent Intravenous Adminstration Set	Ivent Corp.	FPA	Class II	1985-06-07
K852235	Sterets Injection Swab	Ellis Pharmaceutical Consulting, Inc.	LKB	Unclassified	1985-06-07
K852229	Sterile Eye Packs or Trays	Surgeon Surgical Instrumentation, Inc.			1985-06-07
K852203	Kimguard Procedure Tray	Kimberly-Clark Corporation	FRG	Class II	1985-06-07
K852106	i.v. Administration Set	Mediflex Intl.	FPA	Class II	1985-06-07
K852078	Spectrum(tentative)	Parke-Davis Co.	FOZ	Class II	1985-06-07
K852073	Vial Syringe Pumps, Se200, Se200b & Se400	Hospal Medical Corp.	FRN	Class II	1985-06-07