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 2264 of 3531

510(k) clearances, page 2264 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K926203	Endoscopic Scissors (Disposable/reusable Shafts)	Weck Endoscopy	GEI	Class II	1993-10-15
K926134	H-220 Press-Fit Acetabular Cup System	Implex Corp.	MEH	Class II	1993-10-15
K925992	Duoderm Transparent Hydrocolloid Dressing	Convatec, A Division of E.R. Squibb & Sons	KMK	Class I	1993-10-15
K924973	Dylnamedics A.s.a.p.	Dynamedics, Inc.	INX	Class II	1993-10-15
K924955	Mdt/harvey Mc-8 and Mc-10	Mdt Corp., Inc.	FLE	Class II	1993-10-15
K922159	Infinity Porous-Coated Trochanteric Module	Wrightmedicaltechnologyinc	LPH	Class II	1993-10-15
K920838	Medsurg Circumcision Tray	Medsurg Industries, Inc.	HFK	Class II	1993-10-15
K934045	Beckman Hdl Cholesterol Reagent	Beckman Instruments, Inc.	LBS	Class I	1993-10-14
K934042	Chemstrip Super Ua Urine Analyzer	Boehringer Mannheim Corp.	KQO	Class I	1993-10-14
K933178	Gdc 3509	Deringer-Ney, Inc.	EJT	Class II	1993-10-14
K932642	Avl 9110Ph Analyzer	Avl Scientific Corp.	CHL	Class II	1993-10-14
K912069	Avi Model 4225 Vented Piggyback IV Admin Set	3M Avi, Inc.	FPA	Class II	1993-10-14
K934452	Hi Band	Argosy Electronics	ESD	Class I	1993-10-13
K933955	Dupont Standard C for the Dimension Clinical Chemistry System	E.I. Dupont de Nemours & Co., Inc.	JIX	Class II	1993-10-13
K933693	Sigma Cx-3 Calibration Standard Level 2	Sigma Chemical Co.	JIX	Class II	1993-10-13
K933453	Multiple	Fortuna Optical Factory, Ltd.	HQZ	Class I	1993-10-13
K933420	Breathing Tube Support	Blake Medical, Inc.	CBH	Class I	1993-10-13
K933167	A-Dec 2912 Duo Cart	A-dec, Inc.	EIA	Class I	1993-10-13
K932855	Hollister Vertical Drain/tube Attachment Device	Hollister, Inc.	KNT	Class II	1993-10-13
K922562	Stimtech Pfx, Catalog Number 78-8540	Stimtech Products	KPI	Class II	1993-10-13
K933862	Ace(tm) Clin Chem Syst W/opt Ion Select Electr(ise)	Schiapparelli Biosystems, Inc.	JGS	Class II	1993-10-12
K933386	Vacutainer Brand Safety-Gard Needle Holder & Needle Disposable Container System	BD Becton Dickinson Vacutainer Systems Preanalytic	GIM	Class II	1993-10-12
K933239	Cv720-727-000, Microtip and Flue Pak	Medtronic, Inc.	LFL	Unclassified	1993-10-12
K933168	A-Dec 3127 Assistant's Wallmount	A-dec, Inc.	EIA	Class I	1993-10-12
K933165	A-Dec 3131 Duo Wallmount (with Instrumentation)	A-dec, Inc.	EIA	Class I	1993-10-12
K933163	A-Dec 2612 Assistant's Cart	A-dec, Inc.	EIA	Class I	1993-10-12
K933144	Gemini Volumetric Infusion Pump/controller	Imed Corp.	FRN	Class II	1993-10-12
K933119	Hi-Lo Treatment Tables	Tri W-G, Inc.	INQ	Class I	1993-10-12
K933051	Zero Gravity Wheelchair Components, Modification	General Components Intl., Inc.	KNN	Class I	1993-10-12
K932887	Access Folate Assay	Siemens Healthcare Diagnostics Inc.	CGN	Class II	1993-10-12
K932648	Quick Switch Laparoscopic Instruments	Microline Pentax, Inc.	GCJ	Class II	1993-10-12
K932544	Ivac Space Saver Volumetric Pump, Model 599	Y	FRN	Class II	1993-10-12
K932518	Tech-Switch Electrosurgical Pencil, Reusable	Conmedcorp	GEI	Class II	1993-10-12
K932272	Closed End/electrocautery Fiberopt Laser Deliv Sys	Lc Ent.	GEX	Class II	1993-10-12
K931549	Model Ez-1 Sing Chan/ez-2 Dual Channel Infus Pump	Y	FRN	Class II	1993-10-12
K931402	Il Test Glucose	Instrumentation Laboratory Co.	CFR	Class II	1993-10-12
K931103	Stryker Stapler System	Stryker Corp.	GDW	Class II	1993-10-12
K930926	Durham; Y Check Set-Luer Lock W/injection Site	Intl. Medical Consultants	FPA	Class II	1993-10-12
K926525	Betastar 1131.02 Mobile Operating Table	Stierlen-Maquet AG	FQO	Class I	1993-10-12
K926453	Synthes (u.s.a.) Anterior Cervical Vertebrae Plate	Synthes (USA) Products LLC	KWQ	Class II	1993-10-12
K926288	Som 6Vi (Surgical Operating Microscope)	JEDMED Instrument Company	FSO	Class I	1993-10-12
K925762	Branemark System Self-Tapping Fixture	Nobelpharma USA, Inc.	DZE	Class II	1993-10-12
K925690	Meridian Ebna Test Kit	Fuller Laboratories, Inc.	LLM	Class I	1993-10-12
K925689	Meridian Ebv-Igg Test Kit	Fuller Laboratories, Inc.	MCD	Class I	1993-10-12
K925688	Meridian Ebv-Ea Test Kit	Fuller Laboratories, Inc.	LSE	Class I	1993-10-12
K925487	Noblepharma Branemark System Gold Cylinders	Nobelpharma USA, Inc.	DZE	Class II	1993-10-12
K924885	King Size Heat Pad	Conair LLC.	IRT	Class II	1993-10-12
K924837	Disp Monit Pouch /Glove Ck Pat Exam Glove Leak Det	Associated Ent., Inc.	LDQ		1993-10-12
K924800	Mosist Heat Pad with Automatic Off	Conair LLC.	IRT	Class II	1993-10-12
K924799	Moist Heat Pad	Conair LLC.	IRT	Class II	1993-10-12