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 1839 of 3531

510(k) clearances, page 1839 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974543	L-Cath Modified Seldinger Technique Insertion/catheter Exchange Kit Pe-Mst24-24 Ga. Kit, L-Cath Modified Seldinger	Luther Medical Products, Inc.	FOZ	Class II	1998-02-10
K974494	Renamel Flowable Composite	Cosmedent, Inc.	EBD	Class II	1998-02-10
K974484	Isolated Electrosurgical Probes and Devices-Salinetrode	Ximed/Prosure/Injectx	GEI	Class II	1998-02-10
K974397	Sterile Saline for Catheter Care	Baxter Healthcare Corporation	JOL	Class II	1998-02-10
K974381	Candela Gentlelase Gl Dermatological Laser	Candela Corporation	GEX	Class II	1998-02-10
K974359	Frialit-2 Cylinder	Friatec AG	DZE	Class II	1998-02-10
K974358	Frialit -2 Screw	Friatec AG	DZE	Class II	1998-02-10
K974347	Baldur Non-Sterile Cotton Sponges	Baldur Systems Corp.	EFQ	Unclassified	1998-02-10
K974323	Latex Condoms Natural Colour with Silicone Oil Lubricant	Reddy Medtech Health Products, Ltd.	HIS	Class II	1998-02-10
K974295	Byron Medical Aspiration and Infiltration/irrigation Tubing	Byron Medical	KGZ	Class I	1998-02-10
K974287	Fm Receiver - Auditory Trainer	Phonic Ear, Inc.	EPF	Class II	1998-02-10
K974247	40 Cc Grande	Boston Scientific Corporation	DSP	Class II	1998-02-10
K974239	Aktina Medical Physics Corporation Photon Beam Blocking System	Aktina Medical Physics Corp.	IXI	Class II	1998-02-10
K974237	Gsi 70 Audiopath Screener	Grason-Stadler, Inc.	EWO	Class II	1998-02-10
K974235	Amplaid Am50	Amplifon	ETY	Class II	1998-02-10
K974229	Ls-905 Fiberchoice Adapter System	Laser Peripherals LLC	GEX	Class II	1998-02-10
K974222	Ces Masstransit Infusion Catheter	Cordis Neurovascular, Inc.	KRA	Class II	1998-02-10
K973867	Schwartz Electro-Optics, Inc. Crystalase 755 Laser System	Schwartz Electro-Optics, Inc.	GEX	Class II	1998-02-10
K973663	Paljet-B	Golden Gate Bio-Device	DRX	Class II	1998-02-10
K973542	Masky	Pressing di Monticelli Rag. Stefano	EBI	Class II	1998-02-10
K973225	Castle Series 200 Steam Sterilizer (Powerclave)	Getinge/Castle, Inc.	FLE	Class II	1998-02-10
K980191	Manan Biliary Drainage Catheter	Medical Device Technologies, Inc.	FGE	Class II	1998-02-09
K980150	Powder-Free Nitrile Examination Gloves	Masju Sdn. Bhd.	LZA	Class I	1998-02-09
K980130	Abl700 Series Blood Gas , Co-Oximetry, Electrolyte & Metabolite System	Radiometer America, Inc	CHL	Class II	1998-02-09
K980039	Powdered Green Latex Examination Gloves	Sri Johani Sdn. Bhd.	LYY	Class I	1998-02-09
K980038	Powderfree Green Latex Examination Gloves	Sri Johani Sdn. Bhd.	LYY	Class I	1998-02-09
K980037	Powderfree Green Latex Examination Gloves (Polymer Coated)	Sri Johani Sdn. Bhd.	LYY	Class I	1998-02-09
K974853	Latex (Powder Free) Low Protein	P.T. Healthcare Glovindo	LYY	Class I	1998-02-09
K974783	Encore Mark IV Powder Free Surgical Gloves	Ansell Perry	KGO	Class I	1998-02-09
K974580	Allergen Immunocap F256,f245,f207,f202	Pharmacia & Upjohn Company LLC	DHB	Class II	1998-02-09
K974541	Modified Ureteral Indwelling Catheter/stent	Boston Scientific Corporation	FAD	Class II	1998-02-09
K974483	Ntl-Flow	Bisco Inc	EBF	Class II	1998-02-09
K974478	Immuno Concepts Anca Test Systems	IMMUNO CONCEPTS, NA, Ltd.	MOB	Class II	1998-02-09
K974463	Immuno Concepts Anca Test System	IMMUNO CONCEPTS, NA, Ltd.	MOB	Class II	1998-02-09
K974432	Ultraguide 1000	Ultraguide, Ltd.	IYO	Class II	1998-02-09
K974350	Allergan Immuno Cap M4, M8, K70	Pharmacia, Inc.	DHB	Class II	1998-02-09
K974326	Latex Condoms (Natural Colour)	Reddy Medtech Health Products, Ltd.	LTZ	Class II	1998-02-09
K974324	Latex Condoms Colour with Spermicidal Lubricant	Reddy Medtech Health Products, Ltd.	LTZ	Class II	1998-02-09
K974212	Airis II	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1998-02-09
K973692	Ubi Magiwel C-Reactive Protein(crp) Quantitative	United Biotech	DCK	Class II	1998-02-09
K973350	Bio-Rad Microplate 17-Hydroxyprogesterone Test	Bio-Rad	JLX	Class I	1998-02-09
K973221	Composite 168 Restorative System	Dentsply Intl.	EBF	Class II	1998-02-09
K972478	Pre-Loaded Replacement G-Tubes and Accessories	Applied Medical Technologies	KNT	Class II	1998-02-09
K971471	Elastyren Powder-Free Surgical Glove	Eci Medical Technologies, Inc.	KGO	Class I	1998-02-09
K980211	MRI Chiba,spinal,breast Localization,automatic Cutting Needles	Argon Medical Devices, Inc	KNW	Class II	1998-02-06
K980120	Digene Dml 2000 Microplate Luminometer	Qiagen	JJQ	Class I	1998-02-06
K974626	P.t. Machine	Goodman, Goodman & Goodman	JFB	Class II	1998-02-06
K974530	Duffusion-Weighted Mr Imaging Package	Philips North America LLC	LNH	Class II	1998-02-06
K974520	Spyroflex Foam Island Wound Dressing, Spyroflex Foam Island Wound Dressing, Tinted, Spyrofoam	Innovative Technologies (Us), Inc.	MGP	Unclassified	1998-02-06
K974514	External Functional Neuromuscular Stimulator	Neuromotion, Inc.	GZI	Class II	1998-02-06