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 2453 of 3531

510(k) clearances, page 2453 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K911408	Crossfire Laser Assisted Aspiration Cannula	Heraeus Lasersonics, Inc.	GEX	Class II	1991-06-03
K911248	Synermed Urea Nitrogen Reagent Kit	Synermed, Inc.	CDQ	Class II	1991-06-03
K911163	Imagyn Medical Videoscopy Syst W/irrig Pump/access	Imagyn Medical, Inc.	FWF	Class I	1991-06-03
K911067	Norcath Vascular Access Catheters	Norfolk Medical	LJS	Class II	1991-06-03
K911053	Circon Acmi Hydrolaparoscope(tm) Instrument	Circon Video	GCJ	Class II	1991-06-03
K911040	Invotec Microscope Drape	Invotec International, Inc.	HMW	Class II	1991-06-03
K910947	Nev-10 Negative Pressure Ventilator	Lifecare Services, Inc.	BYT	Class II	1991-06-03
K910933	Olympus Angioscopy Irrigation Sheath	Olympus Corp.	DYB	Class II	1991-06-03
K910927	Spencio Skin Guard Kit	Spenco Medical Corp.	KMF	Class I	1991-06-03
K910566	Versacath(tm) Multilumen System	Menlo Care, Inc.	FOZ	Class II	1991-06-03
K910565	Versacath(tm) Selectalumen(tm) W/conversion Tray	Menlo Care, Inc.	FOZ	Class II	1991-06-03
K910550	Condoms/saxon, Gold Circle Coin, Embrace & Rainbow	Safetex Corp.	HIS	Class II	1991-06-03
K910446	Stabident Local Anesthesia System	Fairfax Dental, Inc.	DZM	Class I	1991-06-03
K910263	Charisma	Kulzer GmbH	EBF	Class II	1991-06-03
K905627	Nascor Oxydome	Nascor Pty., Ltd.	BYL	Class I	1991-06-03
K911986	Ramp Rat	Vehicle Dynamics	ITI	Class II	1991-05-31
K911664	Directigen 1-2-3 Pregnancy Controls	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1991-05-31
K911261	Era 2000A	Neotronics, Inc.	BTL	Class II	1991-05-31
K911077	Jain Suture Package Counter	Jain Surgical Equipment, Inc.	MMK	Class II	1991-05-31
K910898	Surgica(tm) H	Hgm Medical Laser Systems, Inc.	GEX	Class II	1991-05-31
K910867	T600 Treadmill	Siemens Burdick, Inc.	IOL	Class I	1991-05-31
K910844	Infusion Pump	Technology Transfer Intl., Inc.	FRN	Class II	1991-05-31
K910831	Endopath Surgical Instruments	Boston Scientific Corporation	GEI	Class II	1991-05-31
K910570	Splinter Tweezers	Solan Scissors Sales	FSM	Class I	1991-05-31
K910024	Volumetric Infusion Pump	Baxter Healthcare Corporation	FRN	Class II	1991-05-31
K905464	Medical Procedure Kits/arterial Blood Sampling	Angiosystems, Inc.	CBT	Class I	1991-05-31
K905374	IV Extension Sets with .22 Micron Filter	Marquette Medical, Inc.	FPA	Class II	1991-05-31
K904813	Visible Light Cure Composite Dental Restor. Mat.	Alpha-Dent	EBF	Class II	1991-05-31
K904310	Rheumagen RF T-Control	Biokit USA, Inc.	DHR	Class II	1991-05-31
K901881	Vibrometry System	Bruel & Kjaer Instruments, Inc.	LNN		1991-05-31
K912214	Bard Singular Biopsy Forceps	C.R. Bard Inc	FCL	Class I	1991-05-30
K911843	Zero-G(tm) Gel/foam Mattress Topper	Steridyne Corp.	KIC	Class I	1991-05-30
K911821	Thermabond Supercast Np or Thermabond Supercast	Dentecon, Inc.	EJH	Class II	1991-05-30
K911667	Hitachi Mrp-7000 Magnetic Rosonance Device	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1991-05-30
K911651	Zefon Baterial/viral Filter	Bill Olson Corp.	CAH	Class II	1991-05-30
K911642	Mrp-5000 and Mrp-7000 Multiplanar Reconstruction	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1991-05-30
K911284	Pulpdent Diamond Polish	Pulpdent Corporation	EJR	Class I	1991-05-30
K911076	Jain Quick Count	Jain Surgical Equipment, Inc.	MMK	Class II	1991-05-30
K910901	Faceplate Ite Hearing Aid Model 28A	Telex Communications, Inc.	LRB	Class I	1991-05-30
K910900	Faceplate Ite Hearing Aid Model Tca	Telex Communications, Inc.	LRB	Class I	1991-05-30
K910758	Micrel Ltd - Portable Infusion Micropump-Mp11	Technology Transfer Intl., Inc.	FRN	Class II	1991-05-30
K910367	Compute-Rx-Comp (Tm)	Medicalibration Physics Consultant Services, Inc.	KPQ	Class II	1991-05-30
K910350	Micrel Ltd-Portable Infusion Pump-Mp20q	Technology Transfer Intl., Inc.	FRN	Class II	1991-05-30
K910091	Ultralite Panelite	Ultralite	IOB	Class II	1991-05-30
K905437	River Medical Microdrill System	River Medical, Inc.	EQH	Class I	1991-05-30
K902102	Com-TENS: a Neurostimulator	Apex Medical, Inc.	GZJ	Class II	1991-05-30
K901810	Micro-Sp Lumbar Puncture (Spinal) Needle	Neuro Technology	BSP	Class II	1991-05-30
K896596	Alpha III Plus and Model P2500f/101 W/optional	Instrumentarium Imaging, Inc.	IZH	Class II	1991-05-30
K911751	Medtrack Treadmill	Quinton, Inc.	IOL	Class I	1991-05-29
K911524	Palfique Estelite	Tokuyama America Inc.	EBF	Class II	1991-05-29