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 2026-10-22, 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 2828 of 3529

510(k) clearances, page 2828 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864252	Thayer-Martin Jembec	Mds Laboratories, Inc.	JTY	Class II	1987-03-31
K864251	Selenite F. Broth	Mds Laboratories, Inc.	JSJ	Class I	1987-03-31
K864250	Sabouraud Dextrose Agar	Mds Laboratories, Inc.	JSJ	Class I	1987-03-31
K864249	Normal Saline Sterile	Mds Laboratories, Inc.	LIB	Class I	1987-03-31
K864248	Mueller Hinton Agar - Supplemented	Mds Laboratories, Inc.	JTZ	Class II	1987-03-31
K864247	Mueller Hinton Agar with 5% Sheep Blood	Mds Laboratories, Inc.	JTZ	Class II	1987-03-31
K864246	Mueller Hinton Agar Large	Mds Laboratories, Inc.	JTZ	Class II	1987-03-31
K864245	Mueller Hinton Agar Small	Mds Laboratories, Inc.	JTZ	Class II	1987-03-31
K864244	Garnerella Vaginalis Identification Kit	Mds Laboratories, Inc.	JTO	Class I	1987-03-31
K864243	Macconkey Agar	Mds Laboratories, Inc.	JSI	Class I	1987-03-31
K864242	Hektoen Enteric Agar	Mds Laboratories, Inc.	JSI	Class I	1987-03-31
K864241	Dnase Agar	Mds Laboratories, Inc.	JSF	Class I	1987-03-31
K864240	Columbia Blood Agar with 5% Sheep Blood	Mds Laboratories, Inc.	JSG	Class I	1987-03-31
K864239	Cled Agar with Andrades Indicator	Mds Laboratories, Inc.	JSH	Class I	1987-03-31
K864238	Chocolate Agar	Mds Laboratories, Inc.	KZI	Class I	1987-03-31
K864237	Cary Blair Transport Medium	Mds Laboratories, Inc.	JSM	Class I	1987-03-31
K870988	Price's Acid-Fast Stain	Devetec, Inc.	JTS	Class I	1987-03-30
K870985	3M Instant Fit Custom Earmold	3M Company	ESD	Class I	1987-03-30
K870982	Hearing Aid	Audioear Electronics	ESD	Class I	1987-03-30
K870906	Carerite Interdental Brushes, Models 3500 & 4500	Cost Rite Health Products, Inc.	EFW	Class I	1987-03-30
K870865	Tissue Culture Bag	American Fluoroseal Corp.	KJA	Class I	1987-03-30
K870856	Cosmos	Pausch Corp.	IYB	Class I	1987-03-30
K870696	Van-Tec Segura Stone Basket W/protective Sheath	Van-Tec, Inc.	FFL	Class II	1987-03-30
K870679	Van-Tec Modular Flexible Cystourethroscope	Van-Tec, Inc.	FBO	Class II	1987-03-30
K870595	T4012 Tsb 2Ml	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-03-30
K870594	T9802 Tsb W/6.5% Nacl	Lakewood Biochemical Co., Inc.	JSD	Class I	1987-03-30
K870593	T9000 Tsb 10Ml	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-03-30
K870592	T4013 Tsb 5Ml	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-03-30
K870557	Van-Tec Pumping System	Van-Tec, Inc.	KOD	Class II	1987-03-30
K870530	Medium 199 with Earle's Salts Product No. M2520	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870529	F-12 Medium, Coon's Modification Product No. F6636	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870499	Mccoy 5A Med (Mod) Suuspension Culture, M6523	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870498	Iscove Mod Dulbecco Med Hybri-Max, Product# I2510	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870497	Bgjb Med(fitton Jackson Mod)w/l-Glut/w/o Sod Bicar	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870496	Dulbecco Modi Eagle Med((dme) Hybri-Max (Tm)	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870495	(Dme) Auto-Mod Modified for Autoclaving #D5280	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870494	Rpmi-1640 Hybri-Max Product No. R8005	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870493	Nutrient Mixture F-12 (Ham) (Hepes Buffered) N4388	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870492	Dulbecco's Modified Eagle Medium Base No. D5030	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870491	Krebs-Ringer Bicarbonate Buffer Product No. K4002	Sigma Chemical Co.	KIP	Class I	1987-03-30
K870490	(Dme) W/1000 Mg Glucose/l No. D4655	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870489	Rpmi 1640 Medium W/l-Glutamine No. R8755	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870488	Rpmi 1640 Medium Defi. Modification No. R7130	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870487	H-Y Medium (Dme:nctc109, 7:1 Mix.) Hybri-Max H9014	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870486	Earle's Balanced Salts (Ebss) Hybri-Max #E9509	Sigma Chemical Co.	KIP	Class I	1987-03-30
K870485	Lactalbumin Hydrolysate (Elah) No. L3762	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870484	Hanks' Balanced Salts (Hbss) No. H1387	Sigma Chemical Co.	KIP	Class I	1987-03-30
K870483	Williams' Medium E W/l-Glutamine #W4125	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870482	(D-Pbs) Modified Hybri-Max Product No. D7030	Sigma Chemical Co.	KIP	Class I	1987-03-30
K870481	(S-Mem) Auto-Mod Product No. M7272	Sigma Chemical Co.	KIT	Class I	1987-03-30