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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 588 of 3529

510(k) clearances, page 588 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K170711	ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System	Zimmer GmbH	PHX	Class II	2017-06-01
K170656	Reinforced Flexible Collagen Nerve Cuff	Collagen Matrix, Inc	JXI	Class II	2017-06-01
K170652	ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls	Fisher Diagnostics	PRI	Class II	2017-06-01
K170490	Celesteion, PCA-9000A/3	Toshibamedical Systems Corporation	KPS	Class II	2017-06-01
K170203	System, Applicator, Radionuclide, Remote Controlled	Kobold, LLC	JAQ	Class II	2017-06-01
K170200	Carbon Dioxide Reagent Set	Teco Diagnostics	KHS	Class II	2017-06-01
K170158	PowerGlide ST Midline Catheter	C.R. Bard Inc	PND	Class II	2017-06-01
K163609	Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)	Pall International, SARL	NHV	Class II	2017-06-01
K162954	OARtrac System with Patient Specific Reusable Universal PSD Sensors	Radiadyne	NZT	Class II	2017-06-01
K162682	MATISSE Anterior Cervical Interbody Fusion Cage System	CTL Medical Corporation	ODP	Class II	2017-06-01
K162389	Medcomp Vessel Dilator	Medcomp ( Medical Components)	DRE	Class II	2017-06-01
DEN160043	Sentinel Cerebral Protection System	Claret Medical, Inc.	PUM	Class II	2017-06-01
K171388	EndoWrist Stapler 45 System and Stapler 45 Reloads	Intuitive Surgical, Inc.	NAY	Class II	2017-05-31
K171387	EMS100 Tri-Wave Combination Stimulator	Elite Medical Supply of New York, LLC	IPF	Class II	2017-05-31
K171338	B R A H M S PCT sensitive KRYPTOR	B.R.A.H.M.S GmbH	PRI	Class II	2017-05-31
K171268	Reverse 021 Micro Catheter, Reverse 027 Micro Catheter	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	DQY	Class II	2017-05-31
K170698	ALLY(TM) Bone Screws	Providence Medical Technology, Inc.	HWC	Class II	2017-05-31
K170670	Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)	bioMerieux, Inc.	JWY	Class II	2017-05-31
K170658	Lympha Press Optimal Plus	MEGO AFEK AC Ltd.	JOW	Class II	2017-05-31
K170626	Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece	Alma Lasers Ltd.	GEX	Class II	2017-05-31
K170573	Empowr CR Knee Tibial Insert	Encore Medical, LP	JWH	Class II	2017-05-31
K170278	OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners	C.R. Bard Inc	GDW	Class II	2017-05-31
K170007	Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens	Acuity Polymers Inc.	HQD	Class II	2017-05-31
K163482	Orthodontic Acrylic 2	Lang Dental Manufacturing Co., Inc.	EBI	Class II	2017-05-31
K162684	Sl 220	Carl Zeiss Meditec Inc	HJO	Class II	2017-05-31
K162601	Infusion Set for Single Use	Shinva Ande Healthcare Apparatus Co., Ltd.	FPA	Class II	2017-05-31
K171314	QLAB Advanced Quantification Software	Philips Health Care	LLZ	Class II	2017-05-30
K171306	gammaCore-S	Electrocore, Inc.	PKR	Class II	2017-05-30
K170954	Portable ECG Monitor	Contec Medical Systems Co., Ltd.	DPS	Class II	2017-05-30
K170899	27Hj713s	LG Electronics Inc.	GCJ	Class II	2017-05-30
K170695	VenaCure EVLT NeverTouch Direct Introducer Sheath	Boston Scientific Corporation	DYB	Class II	2017-05-30
K170604	FilmArray Respiratory Panel 2 (RP2)	BioFire Diagnostics, LLC	OCC	Class II	2017-05-30
K170521	Trinity/3d Prostate Suite	Koelis	IYN	Class II	2017-05-30
K163702	Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1	Toshibamedical Systems Corporation	IYN	Class II	2017-05-30
K163505	Arietta Precision	Hitachi, Ltd.	IYN	Class II	2017-05-30
K163356	Pulse* Spray Infusion System, Uni*Fuse Infusion System	Boston Scientific Corporation	QEY	Class II	2017-05-30
K162574	AmCAD-US	Amcad Biomed Corporation	LLZ	Class II	2017-05-30
K171296	SutureTape	Arthrex GmbH	GAT	Class II	2017-05-26
K171294	da Vinci X Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2017-05-26
K171234	Mistral-Air Warming Unit	The Surgical Company International BV (As the 37company)	DWJ	Class II	2017-05-26
K171230	My Dose Coach	Sanofi S.r.l.	NDC	Class II	2017-05-26
K171229	DELL UP3017 with QUBYX PerfectLum bundle	Qubyx Software Technologies, Inc.	PGY	Class II	2017-05-26
K171217	DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System	Osprey Medical, Inc.	DXT	Class II	2017-05-26
K171059	Nova StatSensor Creatinine Hospital Meter System	Nova Biomedical Corporation	CGL	Class II	2017-05-26
K170839	RAPID Web	Given Imaging Ltd.	NEZ	Class II	2017-05-26
K170692	Respire Pink Series with DentiTrac	Respire Medical Holding	LRK	Class II	2017-05-26
K170659	IQ Technologies	IQ Technologies Inc.	NUH	Class II	2017-05-26
K170216	Flexitouch System	Tactile Systems Technology, Inc. (dba Tactile Medical)	JOW	Class II	2017-05-26
K170178	Ultravision Visual Field Clearing System	Alesi Surgical Ltd	PQM	Class II	2017-05-26
K170133	Ffr V2.5	Philips Volcano	IYO	Class II	2017-05-26