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 2940 of 3529

510(k) clearances, page 2940 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853729	Kestrel Contact Lens Storage Case(polystyrene)	Ryder Intl. Corp.	HPX	Unclassified	1985-12-13
K853728	Kestrel Contact Lens Storage Case(noryl)	Ryder Intl. Corp.	HPX	Unclassified	1985-12-13
K853043	700-123 Eye Shade	Health Saver Products	HQY	Class I	1985-12-13
K853035	Hessburg Light Guard	Visitec Co.	HOY	Class I	1985-12-13
K851560	Portaspir II	Roseburg SA	BTA	Class II	1985-12-13
K852533	l.e.d. Goggles, Model 580-Ledgog	Bio-Logic Systems Corp.	GWE	Class II	1985-12-12
K844853	Nifa Non Invasive Flutter Assembly	Emergency Management Products, Inc.	KDQ	Class II	1985-12-12
K842662	Anti-Epstein-Barr Virus Kit	Amico Lab, Inc.	GNP	Class I	1985-12-12
K854799	Emerson Model 3Mv-Oaa Alarm Module	J. H. Emerson Co.	CCL	Class II	1985-12-11
K854554	Delta-Lite Casting Resin	Johnson & Johnson Professionals, Inc.	LGF	Class I	1985-12-11
K854483	Kallestad Quantimetric Plus Igg Reagent Kit	Kallestad Laboratories, Inc.	KTO	Class I	1985-12-11
K854076	Mga 2000 Gas Analyser	Airspec, Ltd.	DOP	Class I	1985-12-11
K853987	Pall Ec Plus 3Lpm Max. Filter W/sleeve	Pall Biomedical Products Co.	DTM	Class II	1985-12-11
K853950	Arterial/venous Sample Line Bos-Cmsl	American Bentley	DTL	Class II	1985-12-11
K853673	Cardiorater Cr 51	Cardiac Recorders, Ltd.	DRT	Class II	1985-12-11
K840367	Pressure Trigger Mod of Smec Intra-Aort	Smec, Inc.	DSP	Class II	1985-12-11
K854735	Mcarthur Microscope Plastic Version with Acc.	Portable Medical Laboratories, Inc.	IBJ	Class I	1985-12-10
K854636	Churchill-He Vented IV Set	Churchill Corp.	FPA	Class II	1985-12-10
K854630	Churchill-Hs Suspended Non-Vented IV Set	Churchill Corp.	FPA	Class II	1985-12-10
K854629	Churchill-H Extension Tube	Churchill Corp.	FPK	Class II	1985-12-10
K854627	Churchill-Hs Suspended Vented IV Set	Churchill Corp.	FPA	Class II	1985-12-10
K854232	Pharmaseal Scrub Care-Surgical Scrub Brush Sponges	American Pharmaseal Div. Ahsc	GEC	Class I	1985-12-10
K854155	Sterile Saline Solution	I M, Inc.	KMJ	Class I	1985-12-10
K854074	Model 200 Infusion Pump	Avi, Inc.	FRN	Class II	1985-12-10
K854073	Model 210 Infusion Pump	Avi, Inc.	FRN	Class II	1985-12-10
K853930	Quantimetrix Biuret Serum Total Protein Assay Kit	Quantimetrix Corp.	CEK	Class II	1985-12-10
K853870	Easy Eyes Tm Lens Carrying Case	Applied Laboratories, Inc.	HPX	Unclassified	1985-12-10
K853806	Ma-400 Emb Feedback Device	Spectral Data Systems	HCC	Class II	1985-12-10
K850754	Medajet Xl - Jet Injector	Mada Medical Products, Inc.	KZE	Class II	1985-12-10
K854563	Disposable Syringes & Needles	Medelec Intl. Corp.	FMF	Class II	1985-12-09
K854524	Kirschner Spinal Product System	Kirschner Medical Corp.	KWP	Class II	1985-12-09
K854520	Pulmo-Aide Model 5610D	The Devilbiss Co.	CCQ	Class I	1985-12-09
K854338	Kirschner Intramedullary Nail System	Kirschner Medical Corp.	HSB	Class II	1985-12-09
K854325	Tricon Unicompartmental Knee System	Richards Medical Co., Inc.	HSX	Class II	1985-12-09
K854270	Murphy Adjustable Splint	Comfortex, Inc.	KQZ	Class I	1985-12-09
K854162	Support Arm	Healthmate, Inc.			1985-12-09
K854069	Polyflex 483-09 Endocardial Implantable Pacinglead	Intermedics, Inc.	DTB	Class III	1985-12-09
K853971	Regulator-Inhalator System	Stephenson Industries, Inc.	BTL	Class II	1985-12-09
K853869	Titaniuim Bone Screw	George Tiemann & Co.	HWC	Class II	1985-12-09
K853840	Life Watch Respiratory Monitor	Revvity Health Sciences, Inc.	CHL	Class II	1985-12-09
K853836	Neuro Pulse II	Nagata Engineering Co.	GZJ	Class II	1985-12-09
K853791	Norton Cardioplegic Quick Cooling Coil 421738-000	Norton Performance Plastics Corp.	DTR	Class II	1985-12-09
K853732	Lifepak 8 Modification	Physio Control, Inc.	DRO	Class II	1985-12-09
K853725	Atrium Plasma Tfe Synthetic Artery	Atrium Medical Corporation	DSY	Class II	1985-12-09
K853661	Millar/galante Precoated Total Knee	Zimmer GmbH	JWH	Class II	1985-12-09
K853442	Model 804 (TENS)	Oriental Medical Supplies, Inc.	GZJ	Class II	1985-12-09
K853249	Rt3600(115v) Rt3600(220/240v)	General Electric Co.	ITX	Class II	1985-12-09
K853072	Coron Pres Monitor Kit Model 80 Left Kit Model 90	Camino Laboratories, Inc.	DYB	Class II	1985-12-09
K852962	Peripheral Nerve Stimulator Model A400	Fisher & Paykel Allied Products, Ltd.	BXN	Class II	1985-12-09
K852892	Medilog M6	Oxford Medilog, Inc.	DSI	Class II	1985-12-09