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 2216 of 3531

510(k) clearances, page 2216 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940213	Universal Cushioned Metal Eye Shield	P.J. Products, Inc.	HOY	Class I	1994-03-24
K940104	Otosonic Mini Pas	Beltone Electronics Corp.	ESD	Class I	1994-03-24
K936257	Ultrathin Flexible Endoscope Tas-211/2.3	Mitsubishi Cable America, Inc.	EOB	Class II	1994-03-24
K936050	Jaw Spreader	Gam Industries, Inc.	KBW	Class I	1994-03-24
K935188	Stretchpower	Orthopedic Development, Inc.	BXB	Class I	1994-03-24
K934567	Sunglasses (Non-Perscription)	Jaan Huey Co., Ltd.	HQY	Class I	1994-03-24
K934486	Cool Laser Optics (Clo) Unit	Cyruschess	GEX	Class II	1994-03-24
K934401	Arthrotek Cannula System	Zimmer GmbH	HRX	Class II	1994-03-24
K934175	Stretchpower(tm) Brand of Stretch Loading Exerciser	Orthopedic Development, Inc.	BXB	Class I	1994-03-24
K933879	Pads Menstrual, Untreat Deodorized, Various Sizes	Universal Health Care Products Canada, Inc.	HHD	Class I	1994-03-24
K933638	Acumed Carpal Tunnel Release Kit	Acu Med, Inc.	HRX	Class II	1994-03-24
K933516	Acu-E Punch	Acuderm, Inc.	LRY	Class I	1994-03-24
K933070	Arthtotek Precision Hand Instrumentation	Zimmer GmbH	HRX	Class II	1994-03-24
K931879	Reflex Htr	Richard-Allan Medical Ind., Inc.	GCJ	Class II	1994-03-24
K930803	Action Patriot Manual Wheelchair	Invacare GmbH	IOR	Class I	1994-03-24
K930254	Davis+geck Reusable Trtocars	Davis & Geck, Inc.	GCJ	Class II	1994-03-24
K925958	Scissor for Laparoscopic Surgery Gu Use	Zinnanti Surgical Instruments, Inc.	GCJ	Class II	1994-03-24
K913468	Uldall Double Lumen Hemodialysis Catheter Set/tray	Cook Inc.	LFJ	Class II	1994-03-24
K940480	Acufex Sub-Acromial Space Measuring Device	Acufex Microsurgical, Inc.	HTJ	Class I	1994-03-23
K940358	X-Large Multi-Function Trauma Dressing	Certified Safety Mfg Inc	EFQ	Unclassified	1994-03-23
K940256	Bioshield Blue Latex Gloves	Chester Labs, Inc.	LYY	Class I	1994-03-23
K940254	Bioshield Blue Powder Free Glove	Chester Labs, Inc.	LYY	Class I	1994-03-23
K940073	Extension Tube, Extension Tube Length 20, & 30	Puritas Health Care, Inc.	FPA	Class II	1994-03-23
K940072	i.v. Set (20 Drops/ml)	Puritas Health Care, Inc.	FPA	Class II	1994-03-23
K936206	Gore Smoother Crucial Tool	W. L. Gore & Associates, Inc.	HRX	Class II	1994-03-23
K936183	Sorin Bcd Advanced Pediatric Blood Cardioplegia Systems	Sorin Biomedical, Inc.	DTN	Class II	1994-03-23
K936133	Percutaneous Tracheostomy Kit	Smiths Industries Medical Systems, Inc.	JOH	Class II	1994-03-23
K935812	Powder-Free Latex Examination Gloves	Shen Wei (USA), Inc.	LYY	Class I	1994-03-23
K935604	Lasersonics Tissue Morcellator Set	Heraeus Surgical, Inc.	GCJ	Class II	1994-03-23
K935356	Captain's Chair Accessory to Amsco Surgical Tables	Amsco American Sterilizer Co.	FWW	Class I	1994-03-23
K935131	Family First Aid Kit	Medical Technologies International, Inc.	LYY	Class I	1994-03-23
K934937	Karl Storz Biop/bask Cut/grasp Dissec/flex/cut Forc	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-03-23
K934846	Sonicator 716	Mettler Electronics Corp	IMG	Class II	1994-03-23
K934181	Acufex Adjustable-Length Cannula	Acufex Microsurgical, Inc.	HRX	Class II	1994-03-23
K933994	Arthrex Tourniquet for Leg Holder	Arthrex GmbH	KCY	Class I	1994-03-23
K933770	Forceps, ENT Instr, ENT Manual Surg Retract/all Type	Mahe-Medizintechnik	LRC	Class I	1994-03-23
K933760	Stb Guedel Airway	Save-T-Breath Distributors C.C.	CAE	Class I	1994-03-23
K933653	Ms 2500	Lsi Intl., Inc.	IPF	Class II	1994-03-23
K933498	External Vein Stripper	Applied Medical Resources Corp	DWX	Class II	1994-03-23
K933084	Check Valve (Fitting)	Merit Medical Systems, Inc.	DTL	Class II	1994-03-23
K933080	Orthotech Dura-Gold Barckets	Orthotech Co., Ltd.	EJF	Class I	1994-03-23
K932896	Hm-0690 Colposcope	Hill-Med, Inc.	HEX	Class II	1994-03-23
K932782	Hm-0660	Hill-Med, Inc.	HEX	Class II	1994-03-23
K931722	Carapace Labor and Delivery Sets	Carapace, Inc.	MLS	Class II	1994-03-23
K931401	Ems	Saratoga Intl., Inc.	IPF	Class II	1994-03-23
K930102	Pulsator 5000	Toys House Industrial Corp.	GZJ	Class II	1994-03-23
K925813	Diagnostic Intravascular Catheter	Target Therapeutics	DQO	Class II	1994-03-23
K925111	House Infrared/video Electronystagmograph System	Eye Dynamics, Inc.	GWN	Class II	1994-03-23
K940747	Silfree 79	Argen Precious Metals, Inc.	EJT	Class II	1994-03-22
K940689	Wall IV Extension Tube	Walla Medical Systems, Inc.	FPA	Class II	1994-03-22