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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3136 of 3528

510(k) clearances, page 3136 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831708	Micro-Structured Surface Hip Prosthesis	Osteonics Corp.			1983-09-15
K830488	Ventilator #1	Ohio Medical Products	CBK	Class II	1983-09-15
K832773	Sheri-I-Slip Intubating Stylet	Sheridan Catheter Corp.	BSR	Class I	1983-09-12
K832758	Red Color-Tinted Tubing	Custom Medical, Inc.	FPK	Class II	1983-09-12
K832718	Emit Cad Procainamide Assay	Syva Co.	LAR	Class II	1983-09-12
K832692	Curity Catheter Strap	The Kendal Co.	KOD	Class II	1983-09-12
K832690	Minimum Essential Med. Eagle M0268	Sigma Chemical Co.	KIT	Class I	1983-09-12
K832689	Mccoy's 5A #M4892 W/l-Glutamine and	Sigma Chemical Co.	KIT	Class I	1983-09-12
K832688	Dulbecco's Modified Eagle #D5523-	Sigma Chemical Co.	KIT	Class I	1983-09-12
K832687	Basal Med. Eagle #B9888 W/l-Glutamine	Sigma Chemical Co.	KIT	Class I	1983-09-12
K832683	Monoject Injectomatic	Sherwood Medical Co.	KZH	Class II	1983-09-12
K832675	Ana Microzyme Test Sys #1610	Clinical Sciences, Inc.	DAA	Class II	1983-09-12
K832672	Four Lumen Blakemore Tube	Inmed Corp.	KNT	Class II	1983-09-12
K832663	Gamma Steril. Capillary Flow Dialy-G15	Travenol Laboratories, S.A.	FKQ	Class II	1983-09-12
K832650	Upsher Fiberbrite Laryngoscope	Michael S. Upsher	CCW	Class I	1983-09-12
K832639	Alt -Lts	Electro-Nucleonics Laboratories, Inc.	CKA	Class I	1983-09-12
K832638	Cortisol Radioimmunoassay Kit	Bioclinical Group	CGR	Class II	1983-09-12
K832632	Albumin Procedure Bcp	Sandare Chemical Co., Inc.	CJW	Class II	1983-09-12
K832631	A-Gent Carbamazepine	Abbott Medical	KLT	Class II	1983-09-12
K832627	Technicon H6000 System	Technicon Instruments Corp.	GKL	Class II	1983-09-12
K832620	Tryptic Soy Broth Media	Carroll Biological Corp.	JSC	Class I	1983-09-12
K832619	Thioglycollate Medium	Carroll Biological Corp.	JSC	Class I	1983-09-12
K832618	Blue Agar	Carroll Biological Corp.	JSI	Class I	1983-09-12
K832617	Xylose Lysine Deoxycholate	Carroll Biological Corp.	JSI	Class I	1983-09-12
K832616	Macconkey Agar Media	Carroll Biological Corp.	JSH	Class I	1983-09-12
K832615	Sf Broth	Carroll Biological Corp.	JSJ	Class I	1983-09-12
K832614	Selenite Broth	Carroll Biological Corp.	JSJ	Class I	1983-09-12
K832613	Mannitol Salt Agar	Carroll Biological Corp.	JSJ	Class I	1983-09-12
K832612	Chocolate Agar & Thayer Martin Agar	Carroll Biological Corp.	JTY	Class II	1983-09-12
K832611	Tryptic Soy Agar	Carroll Biological Corp.	JSG	Class I	1983-09-12
K832609	A.v.r. Knee Length Therapeutic Stock-	The Kendal Co.	DWL	Class II	1983-09-12
K832597	Gerber Precision Care Breast Pump	Gerber Products Co.	HGY	Class I	1983-09-12
K832588	Cin Agar	Laboratory Products, Inc.	JSJ	Class I	1983-09-12
K832584	Tubing Kit 446	Shaban Mfg. Co.	JJE	Class I	1983-09-12
K832583	Sabouraud Dextrose Agar	Acuderm, Inc.	JSJ	Class I	1983-09-12
K832582	Mycosel Agar	Acuderm, Inc.	JSJ	Class I	1983-09-12
K832581	Dtm-Dermatophyte Test Medium	Acuderm, Inc.	JSJ	Class I	1983-09-12
K832577	Seed Agar	Neogen Culture Media	JSA	Class I	1983-09-12
K832576	Base Agar	Neogen Culture Media	JSA	Class I	1983-09-12
K832575	Antibiotic Assay Broth	Neogen Culture Media	JSA	Class I	1983-09-12
K832574	Btb Lactose Agar	Neogen Culture Media	JSH	Class I	1983-09-12
K832573	C.l.e.d. Medium	Neogen Culture Media	JSH	Class I	1983-09-12
K832572	Bile Esculin Agar	Neogen Culture Media	JSI	Class I	1983-09-12
K832571	Bile Esculin Azide Agar	Neogen Culture Media	JSI	Class I	1983-09-12
K832570	Extract Broth	Neogen Culture Media	JSC	Class I	1983-09-12
K832569	Infusion Broth	Neogen Culture Media	JSC	Class I	1983-09-12
K832568	Indole Nitrate Medium	Neogen Culture Media	JSE	Class I	1983-09-12
K832567	Acetaminophen(paracetamol	Bio-Analytics Laboratories, Inc.	LDP	Class II	1983-09-12
K832564	Disco Sunglasses/headband Sunglasses	E-Tay Industrial Co., Ltd.	HQY	Class I	1983-09-12
K832562	Serum Hcg Assay	Monoclonal Antibodies, Inc.	JHI	Class II	1983-09-12