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 2987 of 3529

510(k) clearances, page 2987 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843829	K-Mesh	Katecho LLC			1985-06-05
K852288	Cellgro	Mediatech, Inc.	KIT	Class I	1985-06-04
K852206	Hep-2 Gencells	Genus Diagnostics	KIR	Class I	1985-06-04
K852205	Rmk Gencells Culture System	Genus Diagnostics	KIR	Class I	1985-06-04
K852204	Mccoy Gencells	Genus Diagnostics	KIR	Class I	1985-06-04
K852184	Electro-Cautery Knife Cleaner 6000 1	Dlp, Inc.	HAM	Class II	1985-06-04
K852110	Ids Rapid E Plus System	Innovative Diagnostic Systems, Inc.	JSS	Class I	1985-06-04
K852064	Dri-Form Pseudomonas Agar F	Gibco Laboratories Life Technologies, Inc.	JSH	Class I	1985-06-04
K851978	Lyfo-Kwik Omi Kit	Micro-Bio-Logics	JSS	Class I	1985-06-04
K851970	Qualitone Stock Canal Aid	Qualitone	ESD	Class I	1985-06-04
K851668	Prosthesis or Surgical Pads	Virginia Hall, Inc.	GBI	Class I	1985-06-04
K851648	Heracor System Heracor Platinum Foil, Blendgold Ne	Heraeus Dental Gold Corp.	EJS	Class II	1985-06-04
K851421	S-Rom Acetabular Cup(part of S-Rom 135Tm Total Hip	Joint Medical Products Corp.	LPH	Class II	1985-06-04
K851399	Bac-T-Screen	Marion Laboratories, Inc.	JXA	Class I	1985-06-04
K851196	Incision Drain	Sil-Med Corp.	GCD	Class I	1985-06-04
K851084	Economy 400 Cws with PVC Drains	C.R. Bard Inc	GCY	Class I	1985-06-04
K851063	Tensmed II	Intermedics, Inc.	GZJ	Class II	1985-06-04
K851015	Ta-20 Automatic Industiral Audiometer	Teledyne Avionics Div. of Teledyne	EWO	Class II	1985-06-04
K850435	Sartorius Aquasart Sm 40035 - Dialysate Sys	Sartorius Filters, Inc.	FKR	Class II	1985-06-04
K850393	Flexible Fiberoptic Endoscope	Microvasive			1985-06-04
K850294	Canal Finder	Roseburg SA	EGS	Class I	1985-06-04
K850264	Tuttnauer Pre-Vacuum Autoclave	Tuttnauer Ltd.	FLE	Class II	1985-06-04
K850109	Nomad Tm-3400	Tracor Northern, Inc.	GWF	Class II	1985-06-04
K844762	Meningococcus Group B Monoclonal Antibody Zm-51	Wellcome Diagnostics	GTJ	Class II	1985-06-04
K852150	Clinical Widefield Specular Micriscope 500	Keeler Instruments, Inc.	HRM	Class I	1985-06-03
K852080	Pennine Suction Catheters	Pennine Medical, Ltd.	BSY	Class I	1985-06-03
K852079	Pennine Derby Yankauer	Pennine Medical, Ltd.	BSY	Class I	1985-06-03
K851994	Ast Aspartate Aminotransferase Reagent	Alpkem Corp.	CIT	Class II	1985-06-03
K851908	Integrity Eye Drop Guide	Integrity Optics, Inc.			1985-06-03
K843950	Link Cementless Screw-in Acetabular Cup	Waldemar Link GmbH & Co. KG	KWA	Class III	1985-06-03
K843940	Link Cementless Screw-in Acetabular Cup	Waldemar Link GmbH & Co. KG	KWA	Class III	1985-06-03
K852149	Portasun Model 600/Li Sunlamp	Portasun, Ltd.	FTC	Class II	1985-05-31
K852103	Inorganic Phosphorus Liquid Stable Reagent Inorgan	Medical Analysis Systems, Inc.	CEO	Class I	1985-05-31
K852068	Total Bilirubin Standards	Data Medical Associates, Inc.	JIS	Class II	1985-05-31
K852067	Direct Biliruben Calibrations	Data Medical Associates, Inc.	JIT	Class II	1985-05-31
K852047	Sc-360 Spectrophotometer	Pharmacia, Inc.	JJQ	Class I	1985-05-31
K852003	Ip Acid Reagent Ip Moly Bdate Reagent	Alpkem Corp.	CEO	Class I	1985-05-31
K851996	Ld-L Reagent	Alpkem Corp.	CFJ	Class II	1985-05-31
K851980	Endab Tsh	IMMUNOTECH s.r.o.	JLW	Class II	1985-05-31
K851942	Coulter Double Check, Unassayed Serum Chemistry	Coulter Electronics, Inc.	JJY	Class I	1985-05-31
K851654	Omnimed Clamp	Omni Intl., Inc.	HXD	Class I	1985-05-31
K851298	Mid Labs Mvsxi	United Sonics, Inc.	HQC	Class II	1985-05-31
K851212	United Sonics Paco System Model 3000	United Sonics, Inc.	HQC	Class II	1985-05-31
K851210	United Sonics Phaco Module, Df-35	United Sonics, Inc.	HQC	Class II	1985-05-31
K851209	Cilco/united Sonics Phace Pf-9000	United Sonics, Inc.	HQC	Class II	1985-05-31
K851191	Electro-Nerve Stimulator Disco B9 TENS	BioMedical Life Systems Inc.	GZJ	Class II	1985-05-31
K851120	Delfia Htsh Kit	Lkb Instruments, Inc.	JLW	Class II	1985-05-31
K850981	Crestline Cb Behind-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1985-05-31
K850860	Axon II Brand of Dual Channel TENS	Cassandra Electronics Corp.	GZJ	Class II	1985-05-31
K850849	Myometer EMG Biofeedback Device	Physio Technology, Inc.	HCC	Class II	1985-05-31