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 2155 of 3531

510(k) clearances, page 2155 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943600	Uniheart	Vortran Medical Technology 1, Inc	CAF	Class II	1994-10-13
K943404	3301 Pulse Oximeter	Bci Intl., Inc.	DQA	Class II	1994-10-13
K942731	Shimazu Whole Body X-Ray CT Scanner Sct-4800Tf/gr	Shimadzu Corp.	IZO	Class I	1994-10-13
K942149	Powdered Disposable Latex Exam Gloves/annexures	Ti-Mate Prophylactic Devices, Ltd.	LYY	Class I	1994-10-13
K942110	Inject-Snare	Endovations	FDI	Class II	1994-10-13
K941998	Ocu-Flex-38 (Polymacon)	Ocu-Ease Optical Products, Inc.	LPL	Class II	1994-10-13
K941351	Burdick Pro2 Oximeter	Burdick Corp.	DQA	Class II	1994-10-13
K940872	Patient Support System	Arylift, Inc.	FNG	Class II	1994-10-13
K940792	Aggro/link Vw Cofactor Software	Chrono-Log Corp.	JOZ	Class II	1994-10-13
K940257	Hand-Held Nebulizer	Nutec, Inc.	CAF	Class II	1994-10-13
K934895	Glassman Silicone Catheter	Axiom Medical, Inc.	EZL	Class II	1994-10-13
K934649	Galileo Endoscopes	Galileo Electro-Optics Corp.	FBO	Class II	1994-10-13
K933588	Aphlelisa Kit	Louisville Apl Diagnostics Inc	MID	Class II	1994-10-13
K931423	Paradigm Femoral Stem, Perfecta Total Hip System	Orthomed, LLC	LWJ	Class II	1994-10-13
K922547	Quantase Phenylalanine Assay	Porton Cambridge, Ltd.	JNB	Class II	1994-10-13
K944077	Program 3-Ch Series Hear Aids W/dt-1 Desktop Program	Argosy Electronics	ESD	Class I	1994-10-12
K944775	Electrosurgical Unit Model 26-0335	Cameron-Miller, Inc.	GEI	Class II	1994-10-11
K944640	Laparoscopic Surgical Instrument/accessory Kit	Gabris Surgical Corp.	FBQ	Class II	1994-10-11
K944317	Genesis 2000	Ion Laser Technology	GEX	Class II	1994-10-11
K944206	Genesis 2000	Ion Laser Technology	GEX	Class II	1994-10-11
K944049	Oxygen Mouthguard	Endovations	MNK	Class I	1994-10-11
K943972	Euro Tech Diamond Chiropractic Table	Progressive Electrical Therapeutics	INQ	Class I	1994-10-11
K943921	Ryder Contact Lens Case	Clinical Research Assoc.	LRX	Class II	1994-10-11
K943731	Video Otoscope	Cuda Products Co.	ERA	Class I	1994-10-11
K943665	Nasal Endoscopy & Sinuscopy Hand Instruments	OLYMPUS Corporation of the Americas	EOB	Class II	1994-10-11
K943379	Phaco Tips for Phaco Fragmentation Machines	Oasis Medical, Inc.	HQC	Class II	1994-10-11
K943325	Tympanostomy Tube	Grace Medical, Inc.	ETD	Class II	1994-10-11
K943253	Innerdyne Step Trocar Expandable Port, S.t.e.p.	Innerdyne Medical, Inc.	GCJ	Class II	1994-10-11
K942108	Cohort Bone Brush	Advanced Med/Surg, Inc.	HWE	Class I	1994-10-11
K940847	Endoscopic Plantar Fascia Kit	Citation Medical Corp.	HRX	Class II	1994-10-11
K936272	Philips Tomoscan Sr 4000	Philips North America LLC	JAK	Class II	1994-10-11
K935295	Alta Femoral Intramedullary Rods/cfx Rods Modification	Howmedica Corp.	HSB	Class II	1994-10-11
K935009	Pegasus	Advanced Technology Laboratories, Inc.	IYN	Class II	1994-10-11
K934070	Tina-Quant Hemoglobin A1c	Boehringer Mannheim Corp.	LCP	Class II	1994-10-11
K933935	Cks Porous Coated Femoral Component	Techmedica, Inc.	HRY	Class II	1994-10-11
K944754	Amplatz Super Stiff Guidewire	Boston Scientific Corporation	KNY	Class II	1994-10-07
K944707	Isolated Camera Head	Envision Medical Corp.	FWF	Class I	1994-10-07
K944530	Karl Storz Insulated Scissors and Rectal Snares	Karl Storz Endoscopy-America, Inc.	GEI	Class II	1994-10-07
K944091	The Hook-Curved Closed End/elect Fiber Laser Deliv Sys	Lca, Inc.	GEX	Class II	1994-10-07
K944033	Bill Evans-Klenz	Calgon Vestal Div.	FLG	Class I	1994-10-07
K943502	Unigrip	Unisurge, Inc.	GCJ	Class II	1994-10-07
K943351	Maunal Disposable Dental Instruments	Magnum Instruments, Inc.	EKJ	Class I	1994-10-07
K943099	Urinary Catecholamine Kit	Bioanalytical Systems, Inc.	CHQ	Class I	1994-10-07
K942877	Examination Gloves	Masif Healthcare Products Sdn. Bhd.	LYY	Class I	1994-10-07
K942822	Cbc-Line Hematology Linearity Control	R & D Systems, Inc.	JPK	Class II	1994-10-07
K942686	Norelco Clean Air System Model Cam665	Norelco Consumer Products Co.	FRF	Class II	1994-10-07
K942643	Ensure Powder-Free Latex Patient Examination Gloves	Basic Intl., Inc.	LYY	Class I	1994-10-07
K942625	1.2 Micron Air Eliminating Filter	The Medi-Dose Group	FPB	Class II	1994-10-07
K942295	Virotrol Torch	Blackhawk Biosystems, Inc.	JJY	Class I	1994-10-07
K941737	Specialty Assayed Control-1	Helena Laboratories, Corp.	GIZ	Class II	1994-10-07