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 1180 of 3531

510(k) clearances, page 1180 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K072384	Modification to Copios Bone Void Filler Sponge & Paste	DSM Biomedical, Inc.	MQV	Class II	2007-09-21
K072345	Powrsyringe Monitor	Pinyons Medical Technology, Inc.	FMF	Class II	2007-09-21
K072338	Cervitec Plus	Ivoclar Vivadent, Inc.	LBH	Class II	2007-09-21
K072337	Wu's 4-Wheeled Neo Scooter, Model Wt-M4a	Wu's Tech Co., Ltd.	INI	Class II	2007-09-21
K072318	Powrsyringe Injector	Pinyons Medical Technology, Inc.	FMF	Class II	2007-09-21
K072311	Tilite Aero X	TiSport, LLC	IOR	Class I	2007-09-21
K072279	Magnetic Resonance Diagnostic Device	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2007-09-21
K072244	Planmeca Proone	Planmeca Oy	MUH	Class II	2007-09-21
K072224	Zip'r Pc	Global Fabtech Wheelchair (Shanghai) Co., Ltd.	ITI	Class II	2007-09-21
K071982	Modification to: Unity Network Id	GE Medical Systems Information Technologies, Inc.	MWI	Class II	2007-09-21
K071615	Fixafloss	Sybron Dental Specialties, Inc.	EEF	Class I	2007-09-21
K071472	Planet 55	Larsen & Toubro Limited	MWI	Class II	2007-09-21
K071431	Globus Genesy 1100 Stimulator	Domino S.r.l.	IPF	Class II	2007-09-21
K071133	Apexnrg-Blue Electronic Apex Locator	Medicnrg, Ltd.	LQY	Unclassified	2007-09-21
K070937	Multiple Brand Male Latex Condom	Nulatex Sdn. Bhd.	HIS	Class II	2007-09-21
K070291	Medix Natal Care Intensive Care Incubator, Models-Natal Care St-Mx/lx/bx	Medix I.C.S.A.	FMZ	Class II	2007-09-21
K070276	Modification to Passmed Spinal System	Medicrea Technologies	MNI	Class II	2007-09-21
K063861	Gs System	OSSTEM Implant Co., Ltd.	DZE	Class II	2007-09-21
K063798	Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000	Ortho-Clinical Diagnostics, Inc.	GQN	Class II	2007-09-21
K072515	Embrace Gel	Orison Corporation	MUI	Class II	2007-09-20
K072489	Revolution Td-4229 Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2007-09-20
K072440	Vitros Chemistry Products: Ca Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208)	Ortho-Clinical Diagnostics, Inc.	CJY	Class II	2007-09-20
K072368	Conformis Metal Backed Tibial Component	ConforMIS, Inc.	HSX	Class II	2007-09-20
K072161	Biomet Femoral Locking Nail System	Biomet Manufacturing Corp	HSB	Class II	2007-09-20
K072062	Ucp Multiple Drug Screen Test Cups	Ucp Biosciences, Inc.	LFG	Class II	2007-09-20
K072034	Diode Medical Laser Family, Models 4, 6, 30	Quanta System Inc.	GEX	Class II	2007-09-20
K071945	S4 Spinal System	Aesculap Inc	NKB	Class II	2007-09-20
K071859	Stryker Crossfire System	Stryker Corp.	GEI	Class II	2007-09-20
K071827	Always Menstrual Pads	Procter & Gamble Co.	HHD	Class I	2007-09-20
K071816	Harpoon Suture Anchor	Biomet Sports Medicine	HWC	Class II	2007-09-20
K071439	Zimmer Patient-Specific Abutment, Internal Hex, Titanium	ZimVie US Corp LLC	DZE	Class II	2007-09-20
K070478	P.004 Rc Temporary Abutment, P.004 Temporary Healing Abutment (Cap)	Straumann USA, LLC	NHA	Class II	2007-09-20
K063297	Lightlas 561 Opthalmic Photocoagulator	Lightmed Corp.	HQF	Class II	2007-09-20
K061539	Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device	Clinical Innovations, LLC	HFX	Class II	2007-09-20
K072364	Pulsion Pulsiocath Thermodilution Catheters & Accessories	Pulsion Medical Systems AG	KRB	Class II	2007-09-19
K072304	Fibrinogen Calibrator Kit	Siemens Healthcare Diagnostics Inc.	GFX	Class II	2007-09-19
K072283	Dorado Pta Balloon Dilatation Catheter	Bard Peripheral Vascular Inc	DQY	Class II	2007-09-19
K072181	Mini LED Autofocus	Satelec	EBZ	Class II	2007-09-19
K071929	Navitrack System- Partial Hip Resurfacing Universal	Orthosoft, Inc.	HAW	Class II	2007-09-19
K071823	Perma Facial Implants	Surgisil	ODU	Class II	2007-09-19
K071604	Alveolus Aero Dv Tracheobronchial Stent System	Alveolus, Inc.	JCT	Class II	2007-09-19
K071453	Spi Easy 4.0 Abutment	Thommen Medical AG	NHA	Class II	2007-09-19
K071071	Crosslinked Polyethylene Articular Inserts	Smith & Nephew, Inc.	JWH	Class II	2007-09-19
K070979	Pull Tab Squeeze Flush	Abbott Medical	KRA	Class II	2007-09-19
K070922	Modification to Spinal USA Vbr System	Spinal USA	KWQ	Class II	2007-09-19
K070816	Peripheral Guiding Sheath	Micrus Design Technology, Inc.	DYB	Class II	2007-09-19
K063735	Presym Trcg Tracheocardiogram, Model 112	Presym, Inc.	DRT	Class II	2007-09-19
K062003	Neuro Wave 6	Lhasa Oms, Inc.	GZJ	Class II	2007-09-19
K072389	Modification to Hyperq System	Biological Signal Processing, Ltd.	MWI	Class II	2007-09-18
K072357	Newtom Vg Computed Tomography X-Ray System	Afp Imaging Corp.	MUH	Class II	2007-09-18