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 2242 of 3531

510(k) clearances, page 2242 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934405	Precedent	Reliance Orthodontic Products, Inc.	EMA	Class II	1994-01-21
K934347	Antifog	Norpak Mfg., Inc.	GCJ	Class II	1994-01-21
K934343	Glaser Rt60, Rt80, Rt150 Audiometer	Glaser Instruments AG	EWO	Class II	1994-01-21
K934342	Glaser Rt450 Hearing Aid Test and Analysis System	Glaser Instruments AG	ETW	Class II	1994-01-21
K934265	Flexmedics Super-Seven Stranded Nickel-Titanium Archwire	Flexmedics	DZC	Class I	1994-01-21
K933663	Modification of Acuson V510b Transducer	Acuson Corp.	ITX	Class II	1994-01-21
K932001	Allison Medical Syringe	Allison Medical, Inc.	FMF	Class II	1994-01-21
K931846	Bio-Prep	Biomedical Devices, Inc.	LXH	Class I	1994-01-21
K931621	Acufex Pro-Pac and ISO-Pac	Acufex Microsurgical, Inc.	HRX	Class II	1994-01-21
K931488	Ksf Spinal Fixator	Franklin Medical USA, Inc.			1994-01-21
K931288	Isolair 2 Full Face Splash Guard	Louis M. Gerson Co., Inc.	LYU	Class I	1994-01-21
K931093	Quick-Connect 360 Swivel Tip Autoclavable Syringe	Dentalez Group	EIA	Class I	1994-01-21
K930939	Rebaron Lc	GC America Inc.	EBI	Class II	1994-01-21
K930881	Channel-Edge Bracket System	Dualtek, Inc.	EJF	Class I	1994-01-21
K930759	Cp & S Sterile Burn Sheet	Consolidated Products & Services, Inc.	FPY	Class I	1994-01-21
K930629	Acryl-X II System	Sonokinetics, Inc.	LZV	Class II	1994-01-21
K925746	Replica	Matech, Inc.	ELW	Class II	1994-01-21
K925072	Amk Landmark Revision Knee System	Depuy, Inc.	JWH	Class II	1994-01-21
K924716	Nico Dental Alloy	Co-Nick Alloys (India), Ltd.	EJH	Class II	1994-01-21
K935817	Medsim 300 Patient Simulator	Dynatech/Nevada, Inc.	DRT	Class II	1994-01-18
K935547	Cal 1 and Cal 2 Standards/standards for Il 501 Sodium/potassium Analyzer	Alko Diagnostic Corp.	JIX	Class II	1994-01-18
K935203	Wound Hydrogel And/or Sterile Wound Hydrogel	Renaissance Medical, Inc.	MGQ	Unclassified	1994-01-18
K935032	Zenith Total Etch 10% Phosphoric Acid	Foremost Dental Mfg., Inc.	EBF	Class II	1994-01-18
K935022	Scimed Entre II Ptca Guide Wire Modification	Scimed Life Systems, Inc.	DQX	Class II	1994-01-18
K935018	Reagents for Orion 1020, and Related Analyzers	Alko Diagnostic Corp.	JIX	Class II	1994-01-18
K934696	Angioscope	Intramed Laboratories, Inc.	LYK	Class II	1994-01-18
K934378	Scimed Maverick Percutaneous Transluminal Angioplasty (Pta) Catheter	Scimed Life Systems, Inc.	LIT	Class II	1994-01-18
K934019	Excel Formula Heat-Auto Cure Dent Base/repair/ortho	St. George Technology, Inc.	EBI	Class II	1994-01-18
K933758	Regency Plus Bracket	Mid-American Dental Specialties, Inc.	EJF	Class I	1994-01-18
K933603	Leadwire	Sentry Medical Products, Inc.	DSA	Class II	1994-01-18
K933507	Needletube Syringe Cartrtidge	Centrix, Inc.	EJK	Class II	1994-01-18
K931298	Signa Advantage 1.Ot Magnetic Resonance System	General Electric Co.	LNH	Class II	1994-01-18
K926190	Alrand Inc. (Dental Hand Instruments)	Alrand, Inc.	EJP	Class I	1994-01-18
K923299	Aplicare One Compund Benzion Tincture Swabstick	Aplicare, Inc.	KMF	Class I	1994-01-18
K935941	Ready Cut Gauze Gauze Bolts	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935940	Gauze Sponge; Drain Sponge	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935939	Gauze Fluff	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935938	Bandage Rolls, Stretch Gauze Rolls, Textured Gauze Rolls	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935937	Post Op Sponge	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935936	Conforming Roll	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935935	Burn Gauze Pads	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935933	Custom Burn Dressing	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935932	Burn Compress	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935931	Non-Woven Sponge	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-14
K935821	Double Trach Swivel Connector	Nutec, Inc.	BZA	Class I	1994-01-14
K935582	Tube, Inhaler Oxygen	Puritas Health Care, Inc.	BZO	Class I	1994-01-14
K935553	Mully Suction Straight with Fingertip/with Funnel/with Vacutip	Puritas Health Care, Inc.	BSY	Class I	1994-01-14
K935400	Fonix 3500 Hearing Aid Analyzer	Frye Electronics, Inc.	ETW	Class II	1994-01-14
K934988	9 French Large Lumen Triguide Plus Guiding Catheter	Scimed Life Systems, Inc.	DQY	Class II	1994-01-14
K934887	9750 Athena Ethernet Option	S & W Medico Teknik	DXK	Class II	1994-01-14