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 2790 of 3530

510(k) clearances, page 2790 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873458	Howmedica Pca Collared Femoral Stem	Howmedica Corp.	JDG	Class II	1987-09-23
K873407	Rrt System Laser Reflectometer Analyzer	Incstar Corp.	JZW	Class I	1987-09-23
K873406	Rrt Short Ragweed Test Kit	Incstar Corp.	DHB	Class II	1987-09-23
K873401	Turbox	Unipath, Ltd.	JZW	Class I	1987-09-23
K873228	Levine Eosin Methylene Blue Agar (Lemb) - #P1507	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-09-23
K873227	Mannitol Salt Agar (Msa) Product #P1706	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-09-23
K873226	Xylose Lysine Deoxycholate Agar - Product #P3601	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-09-23
K873225	Eosin Methylene Blue Agar (Emb) - Product #P1309	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-09-23
K873224	Brain Heart Infus Agar W/5% Sb & Gentamicin-#P3772	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-23
K873223	Macconkey Agar - Product #P1606	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-09-23
K873222	Brain Heart Infusion Broth W/x and V - #T4540	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-09-23
K873221	Brain Heart Infusion Agar W/5% Sb - Product #P3409	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-09-23
K873220	Brain Heart Infusion Broth 4.5 Ml - Product #T3003	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-09-23
K873219	Brain Heart Infusion Broth 0.5 Ml - Product #T3583	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-09-23
K873218	Brain Heart Infusion Broth W/6.5% Nac1 - #T3802	Lakewood Biochemical Co., Inc.	JSD	Class I	1987-09-23
K873217	Brain Heart Infusion Broth 10 Ml - Product #T3006	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-09-23
K873216	Brain Heart Infus Agar Slant W/10% Sheep Blood C&c	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-23
K873078	Novametrix Model 505 Pulse Oximeter	Novametrix Medical Systems, Inc.	DQA	Class II	1987-09-23
K872794	Medix Biotech Apolipoprotein a-I Test Kit	Medix Biotech, Inc.	MSJ	Class I	1987-09-23
K872722	Expanded Use for Shiley 3L Cardf Plus	Shiley, Inc.	DTN	Class II	1987-09-23
K872721	Expanded Use for Shiley 3L Cardiotomy Reservoir	Shiley, Inc.	DTN	Class II	1987-09-23
K872720	Shiley Pts Chest Drainage Autotransfusion Set	Shiley, Inc.	DTN	Class II	1987-09-23
K872615	Imatron C-100 Ultrafast CT Scanner	Imatron, Inc.	JAK	Class II	1987-09-23
K872526	CT Pace Catalog Number B7950a	General Electric Co.	JAK	Class II	1987-09-23
K873603	Finnigan Mat Incos 50	Finnigan Corp.	JJO	Class I	1987-09-22
K873583	Auto-Eia	Labsystems, Inc.	JJQ	Class I	1987-09-22
K873553	Wako(tm) Pretest 8A	FUJIFILM Healthcare Americas Corporation	JJB	Class I	1987-09-22
K873349	Easy-Test Emit N-Acetylprocainamide Napa #16649	Em Diagnostic Systems, Inc.	LAN	Class II	1987-09-22
K873282	Carbamazepine Fpia Fluores. Polariza. Immunoassay	Windsor Laboratories, Inc.	KLT	Class II	1987-09-22
K873249	Antinuclear Antibody (Ana) Positive Controls	Cytotech, Inc.	LKJ	Class II	1987-09-22
K873244	Brain Heart Infus Agr Slt W/5% Shp Bld Penic/strep	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K873243	Brain Heart Infus Agar Slt W/5% Sheep Blood #T3286	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-09-22
K873242	Brain Heart Infus Agar Slt W/5% Sheep Blood/gentam	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K873241	Brain Heart Infus Agar W/5% Sb Penicillin/streptom	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K873240	Brain Heart Infusion Agar W/ C&c Slant Tube #T3285	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K873239	Brain Heart Infusion Selective Agar Slant - #T4463	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K873238	Brain Heart Infusion Agar Slant/gentamicin #T4450	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K873237	Brain Heart Infus Agar Slant W/6% Sb Chloramphenic	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K873236	Brain Heart Infusion Agar Slant Tube, - #T2904	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-09-22
K873235	Brain Heart Infusion Agar Pour Tube, - #T3004	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-09-22
K873234	Brain Heart Infusion Agar W/c&c - Product #P3407	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K873233	Brain Heart Infus Agar W/5% Sb & Chloramphenicol	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-09-22
K872976	TENS Pals Plus	Axelgaard Mfg. Co., Ltd.	GXY	Class II	1987-09-22
K872744	Modified Chlamyset Antigen	Orion Corp.	LJP	Class I	1987-09-22
K872509	Linden Stone Extraction Balloon	Hobbs Medical, Inc.	FGE	Class II	1987-09-22
K873450	Tri-Level Ligand Control	Ciba Corning Diagnostics Corp.	JJX	Class I	1987-09-21
K873440	Rule, Pupillary	Allegheny Plastics, Inc.	HMM	Class I	1987-09-21
K873385	Ophthalmic Phaco-Blade	Myocure, Inc.	HNN	Class I	1987-09-21
K872488	Elasto-Gel Cast & Splint Pads	Southwest Technologies Inc	IPM	Class I	1987-09-21
K872476	Replacement Batteries for Medical Instrumentation	Energy Concepts, Inc.	MHX	Class II	1987-09-21