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 2600 of 3530

510(k) clearances, page 2600 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894840	Myodac2 Biofeedback Device	Thought Technology Ltd.	HCC	Class II	1989-10-13
K894759	Allpac(tm) Material	Barrier Concepts, Inc.	EIA	Class I	1989-10-13
K894725	Mediziv Epidural Systems	Mediziv Medical Devices, Ltd.	CAZ	Class II	1989-10-13
K894669	Laser Shielding Tube	Vitaid, Ltd.	BTR	Class II	1989-10-13
K894649	Emerson 33-Cr Chest Respirator	Emerson Intl. Co.	BYT	Class II	1989-10-13
K894614	Bivona Aire-Cuf Adjustable Tracheostomy Tube	Bivona Medical Technologies	JOH	Class II	1989-10-13
K894613	Bivona Fome-Cuf Adjustable Tracheostomy Tube	Bivona Medical Technologies	JOH	Class II	1989-10-13
K894606	Micro-Aire High Speed Drill (2910-000)	Micro-Aire Surgical Instruments, Inc.	EFB	Class I	1989-10-13
K894570	Universal Light Cable	Expanded Optics, Inc.	LDQ		1989-10-13
K894565	Light Bond Sealant with Fluoride	Reliance Orthodontic Products, Inc.	DYH	Class II	1989-10-13
K894457	Carnation Tracheostomy Masks	Dadsun Corp., Ltd.	BYF	Class I	1989-10-13
K894441	Devilbiss Model 6610D	Devilbiss Health Care, Inc.	CCQ	Class I	1989-10-13
K894373	Nipro Dental Needle	Pharma-Plast USA, Inc.	DZM	Class I	1989-10-13
K894209	Enema Kit	Ledins Herbal Healing Systems	KPL	Class II	1989-10-13
K892854	Anesthetic Agent Monitor	Criticare Systems, Inc.	CBQ	Class II	1989-10-13
K892313	Patient Examination Gloves (Latex)	Glove Lines Private, Ltd.	LYY	Class I	1989-10-13
K892311	Patient Examination Gloves	Southern Rubber Industries Co., Ltd.	LYY	Class I	1989-10-13
K892114	Electro-Physio-Feedback-Xrroid* System	Eclosion	HCC	Class II	1989-10-13
K891210	Pocketed Wraps #3009 A,b,c	Pro-Safe Professional Linens, Inc.	KCT	Class II	1989-10-13
K891160	Mic Non-Sterile Latex Gloves	Asia Dynamics Inc.	LYY	Class I	1989-10-13
K891124	Non-Rebreathing Airway and Mask(s) Kits	Airway Products, Inc.	CBP	Class II	1989-10-13
K890498	Freeman Modular Hip Stem Ridged Version	Mizuho Orthopedic Systems Inc	JDI	Class II	1989-10-13
K890331	Freeman Total Hip System Ridged Stem	Mizuho Orthopedic Systems Inc	LWJ	Class II	1989-10-13
K895729	R2 Pace Pad, Model 480	Darox Corp.	DRO	Class II	1989-10-12
K895728	R2 Pace Adaptor Cable, Model 196	Darox Corp.	DRO	Class II	1989-10-12
K895071	Ai5200 Diagnostic Ultrasound System Transducer	Acoustic Imaging	IYO	Class II	1989-10-12
K895032	Zoll Pd 2200 Pacing-Defibrillation Electrodes	Zmi Corp.	LDD	Class II	1989-10-12
K894988	Ciba Corning Magic Lite Prolactin Immunoassay	Ciba Corning Diagnostics Corp.	CFT	Class I	1989-10-12
K894976	Alternate Packaging Conf. of Pacemaker Lead Adap.	Medtronic, Inc.	DTD	Class II	1989-10-12
K894957	Disposable Plastic Vaginal Specula	Zinnanti Surgical Instruments, Inc.	HIB	Class II	1989-10-12
K894933	Perlident	Germiphene Corp.	EJR	Class I	1989-10-12
K894858	Care 5000 System	Care Systems, Inc.	DSI	Class II	1989-10-12
K894747	Precept-Gt(tm) Microsensor Pressure Monitor Cath.	Endosonics Corp.	DXO	Class II	1989-10-12
K894732	Vascular Graft Package (Shelf-Life Extension)	Medtronic, Inc.	DSY	Class II	1989-10-12
K894694	Omnifit Ceramic Morse Taper Head	Osteonics Corp.	LZO	Class II	1989-10-12
K894681	Revised Labeling for Arterial Embolectomy Catheter	Shiley, Inc.	DXE	Class II	1989-10-12
K894579	Clearplan Easy	Unipath, Ltd.	CEP	Class I	1989-10-12
K894540	Telemetry Receiver Accessory for the Cms 8000	Physio Control, Inc.	DXH	Class II	1989-10-12
K894496	Olympus Valvulotome W/fixed Tip	Olympus Corp.	DWX	Class II	1989-10-12
K894476	Calcium (Arsenazo III) for Manual/auto Application	Catachem, Inc.	CJY	Class II	1989-10-12
K894462	Care Disp. Diag. Electrodes, Silver/silver	Labeltape Meditect, Inc.	DRX	Class II	1989-10-12
K894389	Creatinine for Manual or Automated Applications	Catachem, Inc.	GGX	Class I	1989-10-12
K894369	Apdyne Phenol Applicator Kit	Apdyne Medical Co.	KCJ	Class I	1989-10-12
K894318	Datascope Interlock Guide Wire Extension	Datascope Corp.	DQX	Class II	1989-10-12
K894286	Ppg Biomedical Flexible Micro Transducer Catheter	Ppg Industries, Inc.	DXO	Class II	1989-10-12
K893990	P Polymer	Pace West	LDD	Class II	1989-10-12
K893830	Hemo-Alert	Koregon Enterprise, Inc.	DQO	Class II	1989-10-12
K893482	Korn Mandibular Advancer	American Orthodontics	EJF	Class I	1989-10-12
K893225	Couplant Warming Device	Echo Ultrasound	IYO	Class II	1989-10-12
K891992	Tenzcare Stimulator 6890	3M Company	GZJ	Class II	1989-10-12