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 2026-11-02, 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 966 of 3531

510(k) clearances, page 966 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110845	Impella Controller with Flow Control	Abiomed, Inc.	KFM	Class II	2011-04-27
K110764	Filmarray Rp Panel	Idaho Technology, Inc.	OCC	Class II	2011-04-27
K110502	Triplex Er. Yag / Nd: Yag System	Sandstone Medical Technologies, LLC	GEX	Class II	2011-04-27
K110331	Sensititre Aim (Tm)	Trek Diagnostic Systems, Ltd.	LIE	Class II	2011-04-27
K110282	Lighty Dd Infusion Set	Medx-Set, Ltd.	FPA	Class II	2011-04-27
K103842	Unicel Dxc 600 Synchron System Software Version 5.0 and Unicel Dxc 800 Synchron System Software Version 5.0	Siemens Healthcare Diagnostics Inc.	CGA	Class II	2011-04-27
K103599	Universal Digital Interface (UDI) 1717	Meridian Medical Systems, LLC	MQB	Class II	2011-04-27
K103557	Diazyme Hs Crp Assay Kit / Calibrator Set / Control Set	Diazyme Laboratories, Inc.	DCK	Class II	2011-04-27
K103204	Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit Family	Solarc Systems Inc.	FTC	Class II	2011-04-27
K102517	Tiger 500 Series High Speed Handpieces and Attachments	Thunder Tiger Corp.	EFB	Class I	2011-04-27
K102151	Powdered Vinyl Patient Examination Gloves	Hebei Tengda Plastic Co., Ltd.	LYZ	Class I	2011-04-27
K110999	Digital Ultrasonic Diagnostic Imaging System	Edan Instruments, Inc.	ITX	Class II	2011-04-26
K110862	Vapro Plus Intermittent Catheter	Hollister Incorporated	GBM	Class II	2011-04-26
K110849	Prestodr 4143	CMT Medical Technologies, Ltd.	KPR	Class II	2011-04-26
K110834	Aw Volumeshare 5 with Angioviz Option	GE Healthcare	LLZ	Class II	2011-04-26
K110421	Disposable Insulin Syringe	Wenzhou Wuzhou Import & Export Co., Ltd.	FMF	Class II	2011-04-26
K103363	Zeus Elisa Hsv Gc-I Igg Test System	Zeus Scientific LLC	MXJ	Class II	2011-04-26
K102557	Novakone Spherical and Toric Lenses	Alden Optical Labs., Inc.	LPL	Class II	2011-04-26
K110377	Protective Restraint	Medi-Tech Intl. Corp.	FMQ	Class I	2011-04-25
K102194	Solcart B	B. Braun Avitum AG	KPO	Class II	2011-04-25
K100496	Invader Mthfr 1298	Hologic, Inc.	OMM	Class II	2011-04-25
K110837	Revision Prothesis	Smith & Nephew, Inc.	JWH	Class II	2011-04-22
K110671	Winco Stretchair	Champion Mfg, Inc.	INK	Class II	2011-04-22
K110567	C.t.m. Mobility Scooter Hs515(3w)	C.T.M. Homecare Product, Inc.	INI	Class II	2011-04-22
K110395	C.t.m. Mobility Scooter - Model Hs 118	C.T.M. Homecare Product, Inc.	INI	Class II	2011-04-22
K110355	Venx Revolution	Venx, LLC	GAH	Class I	2011-04-22
K103817	Posey Bed	J. T. Posey Co.	OYS	Class I	2011-04-22
K103484	Gsp Neonatal Thyroxine (T4)	Wallac Oy, A Subsidiary of Perkinelmer, Inc.	KLI	Class II	2011-04-22
K102902	Rubbercare Powder Free Latex Examination Glove, Blue Color	Rubbercare Protection Products Sdn Bhd	LYY	Class I	2011-04-22
K102606	Avs Anchor-C Cervical Cage System	Howmedica Osteonics Corp	OVE	Class II	2011-04-22
K111024	Jetpack 2.0	Philips North America LLC	LLZ	Class II	2011-04-21
K110838	Ifuse Implant System	SI-Bone, Inc.	OUR	Class II	2011-04-21
K110787	Tripore Tdd (Ha), Tripore Tdd (Bp90), Tripore Tdd (Bp15)	Orthogem Limited	MQV	Class II	2011-04-21
K110675	Easyra Urea Nitrogen and Creatinine Reagents	Medica Corp.	CDQ	Class II	2011-04-21
K110177	Helena System	Royal Oak Medical Devices	MAX	Class II	2011-04-21
K110139	Curve Image	Curve Dental, Inc.	LLZ	Class II	2011-04-21
K110125	2.4 Mm Va-Lcp Volar Rim Distal Radius System	Synthes (USA) Products LLC	HRS	Class II	2011-04-21
K103770	Same/various Distributors/ We May Private Label	Syntex Healthcare Products Co., Ltd.	LZA	Class I	2011-04-21
K103766	Xpert Flu, Genexpert Dx Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0	Cepheid	OQW	Class II	2011-04-21
K103602	Eudermic Mp Latex Examination Glove-Blue (Tested for Use with Chemotherapy Drugs) W/ a Protein Content Label Claim	MEDLINE INDUSTRIES, LP - Northfield	LYY	Class I	2011-04-21
K103324	Precision Liquid Oxygen System	Precision Medical, Inc.	BYJ	Class II	2011-04-21
K103194	Intra-Lock Dental Implants with Blossom	Intra-Lock International	DZE	Class II	2011-04-21
K100862	Bodyflow P2ch	Physiomed Elektromedizin AG	IPF	Class II	2011-04-21
K110844	Symbia.net	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2011-04-20
K110833	Cre Balloon Dilatation Catheter	Boston Scientific Corporation	FDT	Class II	2011-04-20
K110768	Computed Dental Radiography	Schick Technologies, Inc.	MUH	Class II	2011-04-20
K110626	Jetstream Navitus System; Jetstream G3 Sf System; Jetstream G3 Se System; Jetstream G3 L System	Pathway Medical Technologies, Inc.	MCW	Class II	2011-04-20
K110515	Ucp Drug Screening Test Cups	Ucp Biosciences, Inc.	DIS	Class II	2011-04-20
K110461	Selectra Cs Lead Introducer System	BIOTRONIK AG	DQY	Class II	2011-04-20
K110452	Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, Ll-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2,	Unilens Corp., USA	LPL	Class II	2011-04-20