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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1713 of 3531

510(k) clearances, page 1713 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K992660	Urf Digital - Ot	Siemens Medical Solutions USA, Inc.	OWB	Class II	1999-11-05
K992656	Depuy Total Elbow System	Depuy Orthopaedics Inc.	JDC	Class II	1999-11-05
K992654	Plug 'N View 3D, Version 1.0	Voxar Limited	LLZ	Class II	1999-11-05
K992373	Orbiter St Diagnostic Electrode Catheter & Orbiter St Extension Cable	C.R. Bard Inc	DRF	Class II	1999-11-05
K991486	Ultra-Cbx	Medcanica, Inc.	DWZ	Class II	1999-11-05
K991344	Worldwide Medical Technologies Seeding Spacers	Worldwide Medical Technologies, LLC	KXK	Class II	1999-11-05
K990546	Delsonic 2000	Sds Dental, Inc.	ELC	Class II	1999-11-05
K990103	Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir , Cvr 600 and 1200 Softshe	Sorin Biomedical, Inc.	DTZ	Class II	1999-11-05
K993536	Bio-Rad Coda Neonatal Galt Assay	Bio-Rad	KQP	Class II	1999-11-04
K992853	Pasco Mic and Mic/id Panels, Cefdinir	Pasco Laboratories, Inc.	JTN	Class II	1999-11-04
K990229	Hpa Portable Kidney Preservation System, Model J-1000-1	Justec Medical Products, Inc.	KDN	Class II	1999-11-04
K984631	Bdprobetec Et Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified DNA Assay	Becton Dickinson Microbiology Systems	LSL	Class II	1999-11-04
K993306	Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model 4760 (Typically)	Paladin Medical, Inc.	HAM	Class II	1999-11-03
K993186	Synercid, 15 Ug, Bbl Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1999-11-03
K992726	Pasco Mic and Mic/id Panels, Quinupristin/dalfopristin for Nonfastidious Organisms	Pasco Laboratories, Inc.	JTN	Class II	1999-11-03
K992637	Muse Cardiovascular Information System	General Electric Medical Systems Information Techn	DSI	Class II	1999-11-03
K991884	Siemens Fio2 Sensor	Siemens Medical Solutions USA, Inc.	CCL	Class II	1999-11-03
K991722	Devilbiss 5 Liter Oxygen Concentrator	Sunrise Medical Hhg, Inc.	CAW	Class II	1999-11-03
K991672	Olympus Na-10J-Kb Aspiration Needle	OLYMPUS Corporation of the Americas	FCG	Class II	1999-11-03
K991617	Face-2-Face CPR Protection Shield	Whiteline Plastics, Inc.	CBP	Class II	1999-11-03
K991054	Bravo Multi-Modality System	Nicolet Biomedical, Inc.	GWQ	Class II	1999-11-03
K990683	Axon Mp-1 Micropositioner	Axon Instruments, Inc.	HAW	Class II	1999-11-03
K993517	Combison 530D/voluson 530D, Tissue Harmonic Imaging (Thi) Option	Medison America, Inc.	IYO	Class II	1999-11-02
K993147	Decap	The Kipp Group	FPA	Class II	1999-11-02
K993000	Bard Hydrophilic Coated Guide Wires	C.R. Bard Inc	DQX	Class II	1999-11-02
K992891	Synthes Cerclage Positioning Pin	Synthes (USA) Products LLC	JDQ	Class II	1999-11-02
K992884	Wheelchair (Manual, Not Electrical)	Foshan Machinery & Equipment Import & Export Co.	IOR	Class I	1999-11-02
K992843	The Mayfield / Acciss System with Windows Nt for Cranial Surgery, the Mayfield / Optical Acciss System with Windows Nt F	Ohio Medical Instrument Co., Inc.	HAW	Class II	1999-11-02
K992717	Pasco Mic and Mic/id Panels,quinupristin/dalfopristin	Pasco Laboratories, Inc.	JTN	Class II	1999-11-02
K992623	Mitek Mini Anchor	Mitek Products	DZL	Class II	1999-11-02
K992492	Ptn Test Cartridges for Coaguchek Pro System, Ptn Controls for Coaguchek Pro System	Roche Diagnostics GmbH	GJS	Class II	1999-11-02
K992310	Tonicross Tricycles, Models, T0, T1,t2,t3 and T4.	Rupiani Medical	IOR	Class I	1999-11-02
K992001	Tray-Link	Silicon-Und Composite Spezialitaten GmbH	ELW	Class II	1999-11-02
K991975	Seraquest Eb Na Igg	Quest Intl., Inc.	LSE	Class I	1999-11-02
K991954	The Bruno Powerbase, Model Psb-2200	Bruno Independent Living Aids, Inc.	ITI	Class II	1999-11-02
K991829	Cdtox a Oia	Biostar, Inc.	LLH	Class I	1999-11-02
K991592	Ksea De La Plaza Blepharoplasty Set	Karl Storz Endoscopy-America, Inc.	HNI	Class I	1999-11-02
K991241	If8000	Dan Med, Inc.	IPF	Class II	1999-11-02
K991015	Lm-70 (Lidofilcon a) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Lathe-Cut)	Lamda Polytech, Ltd.	LPL	Class II	1999-11-02
K990788	Ad-Tech's Foramen Ovale Electrode	AD-Tech Medical Instrument Corp.	GZL	Class II	1999-11-02
K993477	Hrw Wrist Array Coil	Mri Devices Corp.	MOS	Class II	1999-11-01
K993387	Ipump Pain Management System, Model 2L3107k	Baxter Healthcare Corporation	FRN	Class II	1999-11-01
K993223	Rapicure 200 (Curing and Whitening Light)	Mediphotonix, LC	EBZ	Class II	1999-11-01
K993034	Medica Indirect Immunofluorescence (Iif) Anti- Endomysial Antibody (Aema) Test Kit, Model 6001-Esd	Medica Corp.	MVM	Class II	1999-11-01
K992976	K-Assay Myoglobin Assay, K-Assay Myoglobin Calibrator	Kamiya Biomedical Company, LLC	DDR	Class II	1999-11-01
K992704	Il Test Von Willebrand Factor	Instrumentation Laboratory Co.	GGP	Class II	1999-11-01
K992599	Dideco Ats Autotransfusion Cardiotomy Reservoir	Dideco S.p.A.	DTN	Class II	1999-11-01
K992512	Altiva Corporation Ntr 3.3 Mm Self-Tapping Screw Implants, Altiva Corporation Corporation Ntr-3.3 Mm Self-Tapping Ha Coa	Imcor	DZE	Class II	1999-11-01
K992323	Datex-Ohmeda Cardiocap 5, F-Mx, F-Mxg and Accessories	GE Healthcare	MLD	Class II	1999-11-01
K991483	Abbott Architect Glycated Hemoglobin	Abbott Medical	LCP	Class II	1999-11-01