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 2730 of 3530

510(k) clearances, page 2730 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880877	Contrast Injection Device	Med-West, Inc.	DXT	Class II	1988-05-31
K880823	Amerlite Digoxin Assay, Lan.0700/2700, 240/144 Kit	Amersham Corp.	KXT	Class II	1988-05-31
K880746	Sterile Needle for Blood Collection	Applied Plastics Technology, Inc.	FMI	Class II	1988-05-31
K880705	Therapeutic Drug Standard	Verichem Laboratories, Inc.	DKB	Class II	1988-05-31
K880584	Uri-Chem(r) Gk,2,3,4c,5cn,6c,7c and 8C	Mach Diag. C/O Wichita State University	CDM	Class I	1988-05-31
K880545	Stimwear Garments, Signal I and Signal II	Stimwear	GXY	Class II	1988-05-31
K880418	Incos 50 Mass Spectrometer	Finnigan Corp.	DOP	Class I	1988-05-31
K880401	Denver Peritoneo-Venous Shunt	Cerenovus, Inc.	KPM	Class II	1988-05-31
K880152	Par(tm) Brand Drug of Abuse Controls	Medical Analysis Systems, Inc.	DIF	Class I	1988-05-31
K875205	Tri-Flow Catheter	Neurodynamics, Inc.	JXG	Class II	1988-05-31
K875167	Horizon 9000	Mennen Medical, Inc.	DXG	Class II	1988-05-31
K875158	Acs Funnel Introducer	Advanced Cardiovascular Systems, Inc.	DYB	Class II	1988-05-31
K874664	Implantable Electrode Lead, Model 030-446	Telectronics, Inc.	DTB	Class III	1988-05-31
K874663	Moxus or Ocm-1 Oxygen Uptake System	Ametek/Thermox Instruments Division	BZL	Class II	1988-05-31
K873151	Model 7200A, Pressure Ventilation Option	Medtronic, Inc.	CBK	Class II	1988-05-31
K881858	Ace Icpm Side Ported Needle	Buckman Co., Inc.	LXC	Unclassified	1988-05-27
K881702	Biotrol Triglycerides Enzymatique UV H.p.	Biotrol, USA, Inc.	CDT	Class I	1988-05-27
K881655	Spectrum(tm) Blood Gas and Electrolyte Control	Biomedical Research & Development Laboratories, Inc.	JJR	Class I	1988-05-27
K881626	Gamma-Glutamyl Transferase	Tech-Co, Inc.	JQB	Class I	1988-05-27
K881596	Fsh Enzyme Immunoassay Test Kit No. Mb-1057	Medix Biotech, Inc.	CGJ	Class I	1988-05-27
K881595	Quidel Pregnancy Test	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1988-05-27
K881443	Lumatag(tm) Tsh Chemiluminescence Immuno. Assay	London Diagnostics, Inc.	JLW	Class II	1988-05-27
K881440	Iq Potassium	BD Becton Dickinson Vacutainer Systems Preanalytic	CEJ	Class II	1988-05-27
K881435	Pregnospia II	bioMerieux, Inc.	JHJ	Class II	1988-05-27
K881373	Amerlite Tt3 Assay, Lan.0003/2003 240/144 Kit	Amersham Corp.	CDP	Class II	1988-05-27
K881357	Emit Convenience Pack: Thyroxine Assay	Syva Co.	KLI	Class II	1988-05-27
K881337	Emds Lidocaine Calibrator Item No. 67Xxx/95	Em Diagnostic Systems, Inc.	DLJ	Class II	1988-05-27
K881326	Hdl Cholesterol Precipitating Procedure	Data Medical Associates, Inc.	LBR	Class I	1988-05-27
K881258	Paramax Alcohol and Ammonia Calibrator, I & II	Baxter Healthcare Corporation	JIX	Class II	1988-05-27
K881257	Ez-Bead Theophylline Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	KLS	Class II	1988-05-27
K881241	Total Bilirubin Reagent	Tech-Neal Scientific, Inc.	CIG	Class II	1988-05-27
K881229	Auto Trol(tm) Control, Levels 1 & 2 #16692 & 16693	Em Diagnostic Systems, Inc.	JJY	Class I	1988-05-27
K881214	Immpulse T, Assay Reagents	Sclavo, Inc.	CDP	Class II	1988-05-27
K881005	Immuchem Human Chorionic Gonadotropin Hormone Hcg	Icn Biomedicals, Inc.	JHI	Class II	1988-05-27
K880917	Lytening 5	Amdev, Inc.	JGS	Class II	1988-05-27
K880880	Raichem(tm) Magnesium Reagent, Enzymatic	Reagents Applications, Inc.	JGJ	Class I	1988-05-27
K880829	Gds Enzymatic Acetaminophen Reagent	Gds Technology, LLC	LDP	Class II	1988-05-27
K880724	Liquid Chromato. Columns	Supelco, Inc.	DPM	Class I	1988-05-27
K880692	Aspartate Aminotransferase Assay Kit (Ifcc)	Diagnostic Chemicals, Ltd. (USA)	CIT	Class II	1988-05-27
K880447	Multi-Function Blood Gas Control	Bionostics, Inc.	JJY	Class I	1988-05-27
K880308	Calcium	Catachem, Inc.	CIC	Class II	1988-05-27
K880294	Dart Phenytoin	Coulter Electronics, Inc.	LFO	Class II	1988-05-27
K875181	Modified Labeling for Toxi-Lab Broad Spectrum	Marion Laboratories, Inc.			1988-05-27
K875029	Abbott Breath Acetone Analyzer	Abbott Medical	JIN	Class I	1988-05-27
K874027	Lipase UV [Toyo]	Advocacy International, Ltd.	CHI	Class I	1988-05-27
K882091	Stair Veyor	Pride Health Care, Inc.	ILK	Class II	1988-05-26
K882090	Hip Saver	Pride Health Care, Inc.	INN	Class I	1988-05-26
K881909	Toshiba Digital Clinical Thermometer	Toshiba Glass Co., Ltd.	FLL	Class II	1988-05-26
K881711	Vicor Models 410B & 410D and Modified 410A Pacema.	Telectronics and Cordis Pacing Systems	DXY	Class III	1988-05-26
K881283	Meadox Intra-Aortic Graft	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1988-05-26