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 2026-10-29, 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 2623 of 3530

510(k) clearances, page 2623 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K892727	Ifa Sensibac Inipenem	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892725	Ifa Sensibac Vancomycin	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892724	Ifa Sensibac Streptomycin	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892723	Ifa Sensibac Polymyxin B	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892722	Ifa Sensibac Cinoxacin	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892719	Ifa Sensibac Erythromycin	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892718	Ifa Sensibac Tetracycline	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892717	Ifa Sensibac Bacitracin	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892715	Ifa Sensibac Nitrofurantoin	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892714	Ifa Sensibac Neomycin	Investigacion Farmaceutica S.A. de C.V.	JTN	Class II	1989-08-03
K892338	Behind-the-Ear Hearing Aid Model 48 Agci	Qualitone	ESD	Class I	1989-08-03
K891783	Rubella Elisa Test System	Zeus Scientific LLC	LFX	Class II	1989-08-03
K891585	Hydro-San Colonic Irrigation System	Specialty Health Products, LLC.	KPL	Class II	1989-08-03
K891580	Intravascular Catheter with Hydrophilic Coating	Boston Scientific Corporation	DQO	Class II	1989-08-03
K891371	Gilsdorf Percu. Endo.-Peg & Percu. Flouro.-Pfg	Entech, Inc.	KNT	Class II	1989-08-03
K891276	Qbc Malaria System	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1989-08-03
K891184	Patient Examination Gloves (Latex)	Healthcare Gloves Sdn Bhd	LYY	Class I	1989-08-03
K890862	Ambulatory Infusion Pump	Medfusion, Inc.	FRN	Class II	1989-08-03
K890402	Mentor Cylinder Protector Tool (Inflatable Penile)	Mentor	FAE	Class II	1989-08-03
K890195	James Surgical System J1000	O.R. Specialties, Inc.	HQE	Class II	1989-08-03
K884183	Burron Teflon-Coated Guidewire	Burron Medical, Inc.	DQX	Class II	1989-08-03
K894418	Raichem(tm) Spia(tm) Iga Reagents	Reagents Applications, Inc.	CZP	Class II	1989-08-02
K894417	Raichem(tm) Spia(tm) Igm Reagents	Reagents Applications, Inc.	DFT	Class II	1989-08-02
K894411	Seratest Ena [Scl-70] Kit	Hemagen Diagnostics, Inc.	LKJ	Class II	1989-08-02
K893842	Cysto Aprons in Various Sizes	Bemiss Jason Corp.	LYU	Class I	1989-08-02
K893826	Qrsystems H.d. Nuclear Imaging Table	Qrsystems, Inc.	IYZ	Class I	1989-08-02
K893640	Software Version, D1.3 and A1.3 for Magnetom	Siemens Medical Solutions USA, Inc.	LNH	Class II	1989-08-02
K893630	Candela Upc Laser Photocoagulator	Candela Corporation	HQF	Class II	1989-08-02
K892520	Breathing Circuit Bacterial Filters	Arbo Medical, Inc.	CAH	Class II	1989-08-02
K891405	Bms-2000 Mobile EEG System	Buckman Co., Inc.	GYE	Class II	1989-08-02
K891076	Capnomac Ii(tm) Anesthesia Multigas Monitor	Datex Division Instrumentarium Corp.	CCK	Class II	1989-08-02
K891013	Medtronic Intravascular Blood Gas Monitoring	Medtronic, Inc.	CCC	Class II	1989-08-02
K894416	Raichem(tm) Spia(tm) Igg Reagents	Reagents Applications, Inc.	KTO	Class I	1989-08-01
K894307	Lawana Patient Examination Gloves	Viri Imports, Inc.	LYY	Class I	1989-08-01
K894252	Lyphochek Immunoassay Plus Control Serum	Bio-Rad	JJY	Class I	1989-08-01
K894192	Patient Examination Gloves	Royal Pacific Intl. Trade, Inc.	LYY	Class I	1989-08-01
K894050	Modified Decannulation Stopper	Premier Medical	JOH	Class II	1989-08-01
K893918	Latex Exam Gloves(mfg: Lingshun Induscomm Ltd Liab	P.C. Commercial, Inc.	LYY	Class I	1989-08-01
K893680	Silicone Bi-Lumen Irrigation Embolectomy Cath.	Cathlab Corp.	DXE	Class II	1989-08-01
K893578	Pharmaseal Medi-Vac Sterile Post-Op Autotrans. Sys	Baxter Healthcare Corporation	CAC	Class II	1989-08-01
K893262	Latex Examination Gloves	S.C. Rubber Co., Ltd.	LYY	Class I	1989-08-01
K892977	Accutouch Patient Exam Gloves	Thai Medical Industries Co., Ltd.	LYY	Class I	1989-08-01
K892837	Steril-Derm Transparent Wound Dressing	Biointerface Technologies, Inc.	NAD	Class I	1989-08-01
K892788	Patient Examination Gloves (Latex)	Dawin Investments, Ltd.	LYY	Class I	1989-08-01
K892782	Patient Examination Gloves (Latex)	Chung Yang Rubber Works (M) Sdn. Bhd.	LYY	Class I	1989-08-01
K892376	Intravision(tm) Arthroscope System (Add'l Appli.)	Concept, Inc.	HRX	Class II	1989-08-01
K891475	Lyphochek(r) Immunoassay Contr Serum (Human) 1,2,3	Bio-Rad	JJX	Class I	1989-08-01
K884802	Cavendish 460/680 Anesthesia Machine	Dentsply Intl.	BSZ	Class II	1989-08-01
K884577	Procedure Ready Trays	Professional Medical Services	FOZ	Class II	1989-08-01
K884296	O Butment	O Co., Inc.	DZE	Class II	1989-08-01