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 1413 of 3531

510(k) clearances, page 1413 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K033470	Simulix Evolution	Nucletron BV	KPQ	Class II	2004-02-04
K032969	Helica Tc Laparoscopic Cutting and Cauterising (Ltc) Probe	Helica Instruments, Ltd.	GEI	Class II	2004-02-04
K032857	Press-Mate Bx-10 Vital Sign Monitor	Colin Medical Instruments Corp.	DXN	Class II	2004-02-04
K032436	Duramax .018 Biliary Stent System	Avantec Vascular Corp.	FGE	Class II	2004-02-04
K032216	Bioptron Pro Light Therapy System and Bioptron Compact III Light Therapy System	Bioptron AG	NHN	Class II	2004-02-04
K030293	Amsure Red Rubber Urethral Catheter	Amsino International, Inc.	EYB	Class II	2004-02-04
K022650	Apex Medical CPAP Rt 21Xx	Apex Medical, Inc.	BZD	Class II	2004-02-04
K033924	Liquichek Urine Toxicology Control (Screen Series)	Bio-Rad Laboratories Inc.	DIF	Class I	2004-02-03
K033889	Bd Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Chloramphenicol 1-32 Ug/ml Gram Positive	Becton Dickinson & Co	LON	Class II	2004-02-03
K033784	Bd Phoenix Automated Microbiology System - Erythromycin 0.0625-8 Ug/ml	Becton Dickinson & Co	LON	Class II	2004-02-03
K033522	Sensititre 18-24 Hours Susceptibility Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2004-02-03
K033036	Br Monitor and Br Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647	Siemens Healthcare Diagnostics Inc.	MOI	Class II	2004-02-03
K032862	Interlab Alkaline Hemoglobin Electrophoresis Test System	Interlab S.r.l.	JBD	Class II	2004-02-03
K032593	Mercury Medical Negative Inspiratory Force (Nif) Disposable Monometer	Mercury Medical	BXR	Class II	2004-02-03
K040057	Mobile Compact Digital Cardiac Camera	Is2 Research, Inc.	KPS	Class II	2004-02-02
K040046	Minxray, Model Hf120/60h Powerplus	Minxray Inc	IZL	Class II	2004-02-02
K033828	CT Compatible Intrauterine Sleeves, Cat #0311, 9406	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2004-02-02
K033825	Orthopacs	Etrauma.Com Corp.	LLZ	Class II	2004-02-02
K033808	Gradia Gum	GC America Inc.	EBF	Class II	2004-02-02
K033662	Synergy Spine Array Coil	Philips North America LLC	MOS	Class II	2004-02-02
K033656	Sauflon Flat Lens Case/sauflon 2003 Barrel Lens Case	Sauflon Pharmaceuticals, Ltd.	LRX	Class II	2004-02-02
K033608	Aquify Multi-Purpose Solution	Alcon Laboratories	LPN	Class II	2004-02-02
K033538	Belimed Steam Sterilizer Top 5000, Series 4 - 8	Sauter AG	FLE	Class II	2004-02-02
K033506	Comprehensive Humeral Fracture Positioning Sleeve	Zimmer GmbH	KWS	Class II	2004-02-02
K033419	Stv Pro 2	Trophy Radiologie	EIA	Class I	2004-02-02
K032628	Portable X-Ray Unit, Models Pxp-15/20/40Hf	United Radiology Systems, Inc.	IZL	Class II	2004-02-02
K032531	Chase Cardiac Analysis System	Chase Medical, Inc.	LLZ	Class II	2004-02-02
K030849	Amnisure Fetal Membranes Rupture Test Model Fmrt1	N-Dia, Inc.	JJX	Class I	2004-02-02
K040141	Emory Cardiac Toolbox Version 2.6	Syntermed, Inc.	KPS	Class II	2004-01-30
K040115	Piccolo Magnesium Test System	Abaxis Inc	JGJ	Class I	2004-01-30
K034064	Fresenius Ultraflo Hpx Hemodialyzer	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2004-01-30
K034062	Cp Sleeve and River Sleeve	Cp Medical	KXK	Class II	2004-01-30
K034061	Modification to Convoy Advanced Delivery Sheath	Boston Scientific Corporation	DYB	Class II	2004-01-30
K034022	Ucla and Cement-on Abutments and Accessories	Diamodent	DZE	Class II	2004-01-30
K033939	Flosense II, Model 29-8040	Sdi Diagnostics, Inc.	BZG	Class II	2004-01-30
K033910	Olympus Urine Calibrator	Cliniqa Corporation	JIX	Class II	2004-01-30
K033811	Freelite Human Kappa and Lambda Free Kits for Use on the Olympus Au Analyzer	The Binding Site	DEH	Class II	2004-01-30
K033796	Kurz Silicone Strips, Models Sf-1, Sf-1W, Sf-1 Bs	Heinz Kurz GmbH Medizintechnik	KHJ	Class II	2004-01-30
K033757	Mts Multiprogram Trial Stimulator System	Abbott Medical	GZB	Class II	2004-01-30
K033651	Olympus Video Ureteroscope, Ntsc	Olympus Winter & Ibe GmbH	FGB	Class II	2004-01-30
K033606	Abbott Axsym B-Type Natriuretic Peptide (Bnp) Microparticle Enzyme Immunoassay (Meia) Test	Axis-Shield Diagnostics, Ltd.	NBC	Class II	2004-01-30
K033590	Erbe Helix Hydro-Jet	Erbe USA Inc	FQH	Class II	2004-01-30
K033182	Prizm Keratome Blade (B.d. Model), Model Mk8530bd	Surgin Surgical Instrumentation, Inc.	HNO	Class I	2004-01-30
K033058	Creatinine Reagent Kit for Beckman Synchron Cx & Cx Delta Systems	DIAMOND DIAGNOSTICS Inc	CGX	Class II	2004-01-30
K033056	Bun Reagent for Beckman Synchron Cx & Cx Delta Reagent	DIAMOND DIAGNOSTICS Inc	CDS	Class II	2004-01-30
K033055	Glucose Reagent for Beckman Synchron Cx & Cx Delta Systems	DIAMOND DIAGNOSTICS Inc	CGA	Class II	2004-01-30
K032765	Street	Permobil, AB	ITI	Class II	2004-01-30
K032199	Esa Plasma Free Metanephrine Analysis Kit	Esa, Inc.	CHQ	Class I	2004-01-30
K030864	Vadi Manual Resuscitator	Vedi Corp.	BTM	Class II	2004-01-30
K030523	Waterlase	Biolase MG LLC	GEX	Class II	2004-01-30