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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2746 of 3530

510(k) clearances, page 2746 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881107	Intracellular Amyloid Histology Control Slides	Sigma Diagnostics, Inc.	LJG	Class I	1988-03-30
K881042	Ats Trichrome Stain (Wheatley's Modification)	Alpha-Tec Systems, Inc.	JTS	Class I	1988-03-30
K880962	Ats Cryptosporidium Stain Control Slides	Alpha-Tec Systems, Inc.	LJG	Class I	1988-03-30
K880945	Camplyobacter Culture Media Products P3873/t3597	Lakewood Biochemical Co., Inc.	JSJ	Class I	1988-03-30
K880729	Kallestad Qm300 Calibrator C Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DCK	Class II	1988-03-30
K880477	Rpr Test for Syphilis in Serum or Plasma	Ampcor, Inc.	GMQ	Class II	1988-03-30
K880165	Trust Rpr Test for Syphilis in Serum or Plasma	Ampcor, Inc.	GMQ	Class II	1988-03-30
K880142	Tsa W/lec. & Tween. 80	Hardy Media	JSG	Class I	1988-03-30
K880141	Bcye, Selective (W/mpa)	Hardy Media	JSJ	Class I	1988-03-30
K880140	Bcye Agar	Hardy Media	JSJ	Class I	1988-03-30
K880139	Onpg Test Reagent	Hardy Media	JSF	Class I	1988-03-30
K880138	Wallenstein Medium Slant	Hardy Media	KZI	Class I	1988-03-30
K880137	Bhi with C & C Slant	Hardy Media	JSJ	Class I	1988-03-30
K880136	Cetrimide Selective Agar	Hardy Media	JSJ	Class I	1988-03-30
K880135	Nitrate Broth	Hardy Media	JSF	Class I	1988-03-30
K880132	Dermatophyte Test Medium	Hardy Media	JSI	Class I	1988-03-30
K880130	Ats Media	Hardy Media	JSI	Class I	1988-03-30
K880129	Brilliant Green Bile Broth	Hardy Media	JSF	Class I	1988-03-30
K880128	Sabouraud Dextrose Agar W/chloro	Hardy Media	JSJ	Class I	1988-03-30
K880118	Moelloers Decarboxylase, Arginine	Hardy Media	JSF	Class I	1988-03-30
K880117	Of Medium Base	Hardy Media	JSH	Class I	1988-03-30
K880113	Cystine Tryptic Medium W/lactose	Hardy Media	JSF	Class I	1988-03-30
K880112	Cystine Tryptic Medium W/ Maltose	Hardy Media	JSF	Class I	1988-03-30
K880111	Cystine Tryptic Medium W/sucrose	Hardy Media	JSF	Class I	1988-03-30
K880110	Cystine Tryptic Medium W/dextrose	Hardy Media	JSF	Class I	1988-03-30
K880109	Cystine Tryptic Medium Base	Hardy Media	KZI	Class I	1988-03-30
K880108	Corn Meal W/polysorbate 80	Hardy Media	JSI	Class I	1988-03-30
K880107	Campy Broth	Hardy Media	JSD	Class I	1988-03-30
K880106	Acetamide Agar Slant	Hardy Media	JSF	Class I	1988-03-30
K880105	Muller Hinton Broth	Hardy Media	JTZ	Class II	1988-03-30
K875286	Lyme Stat Test Kit	Whittaker Bioproducts, Inc.	LSR	Class II	1988-03-30
K875099	Molteno Valve Seton	Staar Surgical AG	KYF	Class II	1988-03-30
K873360	Enteron Percutan. Endoscopic Gastrostomy Tray-Peg	Endovations	KNT	Class II	1988-03-30
K880803	Wako(tm) Iga-Ha Direct	FUJIFILM Healthcare Americas Corporation	CZP	Class II	1988-03-29
K880704	Cerullo Suction Regulator	Aesculap Instruments Corp.	GCX	Class II	1988-03-29
K880597	Thumper Model P-1000	Micro Tek Engineering	BYI	Class II	1988-03-29
K880072	Port-a-Cath Implantable Drug Delivery System	Pharmacia Deltec, Inc.	LLD	Class II	1988-03-29
K875264	Washing Catheter	Endovations	OCX	Class II	1988-03-29
K875183	Lc Oxygen Analyzer	Ametek/Thermox Instruments Division	CCL	Class II	1988-03-29
K875174	Rateminder V Infusion Pump	Critikon Company, LLC	FRN	Class II	1988-03-29
K874724	Sara Agie Monitor	Ppg/Applied Resources, Inc.	CCK	Class II	1988-03-29
K881222	Johnson & Johnson Fluff Sponge	Johnson & Johnson Professionals, Inc.	EFQ	Unclassified	1988-03-28
K881150	Kinetic Fibrinogen Assay	Bio/Data Corp.	GIS	Class II	1988-03-28
K881082	Gv 11 (Tm), Model 9700	Medical Devices Inc.	IPF	Class II	1988-03-28
K880965	Somatom Plus	Siemens Medical Solutions USA, Inc.	JAK	Class II	1988-03-28
K880822	Pics-2000	Philips North America LLC	JAK	Class II	1988-03-28
K880532	Single Phase Diagnostic X-Ray Generator Fx 350	Fischer Imaging Corp.	IZO	Class I	1988-03-28
K880154	Metatech Intracranial Pressure Monitoring System	Metatech Corp.	GWM	Class II	1988-03-28
K880044	Oeco Membrane Oxygne & Vapor Enricher Model Oe-8	Oxygen Enrichment Company, Ltd.	CAW	Class II	1988-03-28
K875367	Colorgene Fluorescent DNA Hybridization Test / Cmv	Enzo Biochem, Inc.	GQM	Class II	1988-03-28