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 2050 of 3531

510(k) clearances, page 2050 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942938	Crossvent-4 Ventilator	Bio-Med Devices, Inc.	CBK	Class II	1995-09-19
K940320	Ad-Tech's Raab Infant Nasopharyngeal Prongs	AD-Tech Medical Instrument Corp.	BTQ	Class I	1995-09-19
K935730	Ebna Igg Elisa Test	Gull Laboratories, Inc.	LLM	Class I	1995-09-19
K933961	Marsam Model 2000 Nebulizer	Marsam Pharmaceuticals, Inc.	CAF	Class II	1995-09-19
K933825	Adi System	Abbott Medical	FRN	Class II	1995-09-19
K954038	K-Amp 16, Hi-Band K-Amp, Ultra Compression & Hearing Protection/hearing Instrument	Argosy Electronics	ESD	Class I	1995-09-18
K953964	Lumisys, Lumiscan 20	Lumisys, Inc.	LMA	Class II	1995-09-18
K953950	Fluoro Catheter	CMT Medical Technologies, Ltd.	JAA	Class II	1995-09-18
K953934	Med-Tech Lung Diffusion Mixture	Medical Technical Gases Inc.	BXK	Class I	1995-09-18
K953921	Phonak 9900 Cic	Phonak, Inc.	ESD	Class I	1995-09-18
K953785	Unicor, Inc. Ventilator Hoses	Unicor, Inc.	BZO	Class I	1995-09-18
K953770	Rexton Mini-Primo Plus, Pp142, D.c .H.i. Family	Rexton, Inc.	ESD	Class I	1995-09-18
K953687	Westmed Pediatric Bacterial/viral Filter	Westmed Intl.	CAH	Class II	1995-09-18
K953464	Westmed Pediatric & Adult Medium Concentration Oxygen Mask	Westmed Inc	BYG	Class I	1995-09-18
K953368	Luer, Jackson Trachea Tubes, Luer Speaking Trachea Tubes	Karl Storz Endoskop GmbH	BTR	Class II	1995-09-18
K953218	Ausculator Gps	Lyte Industries, Inc.	DQD	Class II	1995-09-18
K952914	Star Technologies, Inc. Film Image Scan System	Star Technologies, Inc.	LMD	Class I	1995-09-18
K952888	Olympus Imagemanager System Version 6.0 for Windows	OLYMPUS Corporation of the Americas	LMB	Class I	1995-09-18
K952886	Branemark System Ovoid & U-Shaped Bar System	Nobelpharma USA, Inc.	DZE	Class II	1995-09-18
K952846	Epicardia	Medicomp, Inc.	DQK	Class II	1995-09-18
K952796	Advanced Laser Multiline System, Aly	Advanced Laser Services Corp.	GEX	Class II	1995-09-18
K952685	Branemark System Drills and Countersinks	Nobelpharma USA, Inc.	DZE	Class II	1995-09-18
K952634	Opti-Max Externally Threaded External-Hex Dental Implant, Titanium Plasma-Spray Coated, with Healing Screw	Opti-Max	DZE	Class II	1995-09-18
K951258	Ps Medical Bioglide Csf-Flow Control Shunt Kit	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1995-09-18
K951002	Amendments to Multifocus	Oticon, Inc.	ESD	Class I	1995-09-18
K945827	Outlook	Philips North America LLC	LNH	Class II	1995-09-18
K944615	A620 EEG	Stoelting Co.	HCC	Class II	1995-09-18
K941935	Lp-12 Laparoscopic Probe	Biosound, Inc.	ITX	Class II	1995-09-18
K940861	Pca(r) Modular Total Knee Tib Insert Durocon Baseplate	Howmedica Corp.	JWH	Class II	1995-09-18
K940743	Uhmwpe Components-Change in Packaging	Depuy, Inc.	KWY	Class II	1995-09-18
K954151	Bioaccess Bone Biopsy System	Bioaccess, Inc.	KNW	Class II	1995-09-15
K953927	Linical Protein VI Calibration Verifiers Levels a-E for Beckman Array Protein System	International Enzymes, Inc.	DCF	Class II	1995-09-15
K953926	Linical Protein III Calibration Verifiers Levels a-E for Beckman Array Protein System	International Enzymes, Inc.	DCK	Class II	1995-09-15
K953695	Dyonics Disposable Arthroscopic Blades	Smith & Nephew Dyonics, Inc.	HRX	Class II	1995-09-15
K953652	Prenval I	Base Ten Systems, Inc.	JQP	Class I	1995-09-15
K953641	Maxxus Orthopaedic Surgical Gloves	Johnson & Johnson MEDICAL GmbH	KGO	Class I	1995-09-15
K953611	Dexide Endo-Lube Kit	Dexide, Inc.	GCJ	Class II	1995-09-15
K953580	Heat Moisture Exchanger	Intertech Resources, Inc.	BYD	Class I	1995-09-15
K953506	Westmed Respiratory Luer Adaptor	Westmed Intl.	BXY	Class I	1995-09-15
K953466	Genericuff	Generic Medical, Inc.	DXQ	Class II	1995-09-15
K953433	Midas Rex Telescoping System	Midas Rex Pneumatic Tools, Inc.	GET	Class I	1995-09-15
K953386	9I Oral/maxillofacial Bone Fixation System: Bone Mesh-Plate & Screws	ZimVie US Corp LLC	JEY	Class II	1995-09-15
K953293	Pm Positioner	Jonathan A. Parker, D.D.S.	LQZ	Class II	1995-09-15
K953281	Ha, Tp Cylinder Oval	Implant Center of the Palm Beaches	DZE	Class II	1995-09-15
K953280	Ha, Tp Cylinder, Unihole	Implant Center of the Palm Beaches	DZE	Class II	1995-09-15
K953237	Prosthetics & Instrumentation a. Prosthetic Abutments 4, 5, 6 Diameter, Grade 3, B. Irrigation Drills, Tooling & Preang'	Implant Center of the Palm Beaches	DZE	Class II	1995-09-15
K953039	Various Adult & Child High Con/nonrebreath Oxy Masks	Dadsun Corp., Ltd.	BYG	Class I	1995-09-15
K953019	Hydrophilic Foam Dressing	Busse Hospital Disposables	KMF	Class I	1995-09-15
K952976	Plastic Blunt Cannula	Marquette Medical, Inc.	FPA	Class II	1995-09-15
K952918	PTFE Syringe Filter	B.Braun Medical, Inc.	FMF	Class II	1995-09-15