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 1314 of 3531

510(k) clearances, page 1314 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051601	Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	DYB	Class II	2005-08-04
K051586	Viewsend Medical System	Kenei Co., Ltd.	LLZ	Class II	2005-08-04
K051529	Ambu Neuroline Ground	Ambu A/S	GXY	Class II	2005-08-04
K051496	Cobalt Bone Cement	Zimmer GmbH	LOD	Class II	2005-08-04
K051468	Inner-Lock Introducer Sheath	Rex Medical LP	DYB	Class II	2005-08-04
K051362	Inion Anchron Biodegradable Anchor System, Model Anc-6000	Inion Oy	MAI	Class II	2005-08-04
K050465	Immunalysis Cocaine Elisa for Hair	Immunalysis Corporation	DIO	Class II	2005-08-04
K050430	Merits Health Products Oxygen Concentrator	Merits Health Products, Inc.	CAW	Class II	2005-08-04
K043034	Osteoguide Anorganic Bone Mineral Products	Collagen Matrix, Inc	NPM	Class II	2005-08-04
K052006	Powder-Free Vinyl Exam Gloves	Baoding Guanzhong Glove Co., Ltd.	LYZ	Class I	2005-08-03
K051851	Aviso Ophthalmic Ultrasound System	Quantel Medical	IYO	Class II	2005-08-03
K051818	Beautifil Flow	Shofu Dental Corp.	EBF	Class II	2005-08-03
K051532	Cobalt G Hv Bone Cement	Zimmer GmbH	LOD	Class II	2005-08-03
K051485	Ams Pelvic Floor Repair System	American Medical Systems, Inc.	OTO	Class II	2005-08-03
K051437	Cml 1000	Abbott Medical	FPA	Class II	2005-08-03
K051378	Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)	Medline	LZA	Class I	2005-08-03
K051327	Abbott Axsym B12	Abbott Medical	CDD	Class II	2005-08-03
K050994	Airlife Infant Nasal Continuous Positive Airway Pressure System	Cardinalhealth	BZD	Class II	2005-08-03
K030146	Kavo Key Laser 1242 and Kavo Key Laser 1243+	Kavo America	NVK	Class II	2005-08-03
K052013	Achieva 1.5T & Inera 1.5T Family	Philips Medical Systems Nederland B.V.	LNH	Class II	2005-08-02
K051935	Powder Free Vinyl Patient Examination Gloves, White (Non-Colored)	Shijiazhuang Wonder Plastic Co., Ltd.	LYZ	Class I	2005-08-02
K051855	Ventri	GE Medical Systems F.I. Haifa	KPS	Class II	2005-08-02
K051715	Starpacs Dental	Infinitt Co., Ltd.	LLZ	Class II	2005-08-02
K051649	Vericis Cardiovascular Image and Information System, Model 4.0	Camtronics Medical Systems	LLZ	Class II	2005-08-02
K051639	As-Obgyn Information System; as-Emr System	As Software, LLC	LLZ	Class II	2005-08-02
K051618	Special Procedures II Head Coil, Model 1400Ge-64	Midwest Rf, LLC	MOS	Class II	2005-08-02
K051426	Carlo Surgical Gown	Sofilm Technology Co., Ltd.	FYA	Class II	2005-08-02
K051285	Glucolab Blood Glucose Monitoring System	Infopia Co, Ltd.	CGA	Class II	2005-08-02
K051045	Simplechoice 3.0 Ml Reservoir Pro Reference Number Rp-30	Spectrx, Inc.	FRN	Class II	2005-08-02
K042394	Diagnodent Perio Tip (Accessory)	Kavo America	NBL	Class II	2005-08-02
K051939	Maxplus Tru-Swab Positive Displacement Connector	Medegen Medical Manufacturing System	FPA	Class II	2005-08-01
K051683	Powder-Free Synthetic Vinyl Exam Gloves with Vitamin E Coating	Shen Wei (USA), Inc.	LYZ	Class I	2005-08-01
K051619	Lipoprotein for Multiple Analytes	Medrad, Inc.	JIX	Class II	2005-08-01
K051406	Osteocure Resorbable Bead Kit	Nexa Orthopedics, Inc.	MQV	Class II	2005-08-01
K051122	Itag Mhc Tetramer Cmv Assay	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2005-08-01
K050927	Rt019 Inspiratory/expiratory Filter	Fisher & Paykel Healthcare, Inc.	CAH	Class II	2005-08-01
K051767	Ltv 1000 Ventilator	Pulmonetic Systems, Inc.	CBK	Class II	2005-07-29
K051610	Hans Hermann Laparoscopes and Accessories	Hans Hermann GmbH	GCJ	Class II	2005-07-29
K051590	T2 Ankle Arthrodesis Nail	Howmedica Osteonics Corp	HSB	Class II	2005-07-29
K051429	Claris Non-Stick Bipolar Forceps	Guenter Bissinger Medizintechnik GmbH	GEI	Class II	2005-07-29
K051287	Vari-Lase Endovenous Laser Procedure Kit	Vascular Solutions LLC	GEX	Class II	2005-07-29
K043573	Dynagraft II Dental	IsoTis OrthoBiologics, Inc.	NUN	Class II	2005-07-29
K042562	Lens Plus Rewetting Drops	Advanced Medical Optics, Inc.	LPN	Class II	2005-07-29
K041893	Intralase Fs Laser	Intra Lase Corp.	GEX	Class II	2005-07-29
K051780	Jetlite 5000	J. Morita USA, Inc.	EBZ	Class II	2005-07-28
K051773	Model 3873 1* 8 and Model 3874 1* 8 Compact Test Stimulation Leads	Medtronic Inc.,Neurological Division.	GZB	Class II	2005-07-28
K051739	Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; Pw Doppler Ultraound Probe, Model 2Mpb.	Multigon Industries, Inc.	IYN	Class II	2005-07-28
K051527	Spi Easy Temporary Cap	Thommen Medical AG	NHA	Class II	2005-07-28
K051375	Vital Signs Monitor	Mediana Co., Ltd.	DXN	Class II	2005-07-28
K051343	Mini Ghost Pta Catheter, Model 507	Numed Inc	DQY	Class II	2005-07-28