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 2135 of 3531

510(k) clearances, page 2135 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944834	Unscented Menstrual Tampons	Tambrands Inc.	HEB	Class II	1994-12-21
K944795	Karl Storz Unipolar Ball, Needle, Loop Electrodes	Karl Storz Endoscopy-America, Inc.	FAS	Class II	1994-12-21
K944735	Bio-Logic Emav Emission Averaging Otoacoustic Test	Bio-Logic Systems Corp.	EWO	Class II	1994-12-21
K944729	Stylet Sheath with Locking Cap and Reusable Battery Operated Light Source	Coast Medical Corp.	BSR	Class I	1994-12-21
K944301	Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360 Through 5380	Hudson Respiratory Care, Inc.	BTM	Class II	1994-12-21
K944161	Image	Authorized Hearing Systems, Inc.	ESD	Class I	1994-12-21
K944012	Electrosurgical Flexible Electrode in-Line Suction Coagulator	Aspen Laboratories, Inc.	GEI	Class II	1994-12-21
K943906	P.f.c. Cement Pressurizing System	Johnson & Johnson Professionals, Inc.	KIH	Class I	1994-12-21
K943462	Darwin Knee System	Johnson & Johnson Professionals, Inc.	JWH	Class II	1994-12-21
K943176	Karl Storz Hopkins I&ii/oper/autoclavable Telescopesq	Karl Storz Endoscopy-America, Inc.	FAJ	Class II	1994-12-21
K943055	Electrosurgical Cutting and Coagulating Device and Accessories	Megadyne Medical Products, Inc	GEI	Class II	1994-12-21
K942702	Deep Canal Hearing Instrument	Rexton, Inc.	ESD	Class I	1994-12-21
K940776	Kreativ Model Kv-1	Kreativ, Inc.	KOJ	Class II	1994-12-21
K940729	Pioneer Laboratories Bone Plate with Cerclage Cables	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	1994-12-21
K935985	Deroyal Critical Care Disposable Waste Station	DeRoyal Industries, Inc.	DQO	Class II	1994-12-21
K934799	Conmed Trogard	Conmedcorp	HET	Class II	1994-12-21
K934334	Apogee Hip Stem with Porocoat	Depuy, Inc.	LPH	Class II	1994-12-21
K946023	Karl Storz Telescope Bridges and Adapters	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-12-20
K945465	Cvd Small Vessel Balloon Dilatation Catheter	Cardiovascular Dynamics, Inc.	LIT	Class II	1994-12-20
K945462	Super Poli-Grip Denture Adhesive Cream	Block Drug Company, Inc.	KOT	Class I	1994-12-20
K945297	Infra Vision Imaging System	Gabriel Medical, Inc.	GCJ	Class II	1994-12-20
K944950	Klenzyme	Calgon Corp.	FLG	Class I	1994-12-20
K944920	Cg Disposable Syringe	Fortunique Medical Products	FMF	Class II	1994-12-20
K944864	Primed Rigid Container System	Primed, Inc.	KCT	Class II	1994-12-20
K944138	Interwoven Optiguard Reusable Gown Material	Baxter Healthcare Corporation	FYA	Class II	1994-12-20
K944084	Jeneric/pentron P0wered Toothbrust	Jeneric/Pentron, Inc.	JEQ	Class I	1994-12-20
K944016	Focus Balloon Dilatation Catheter	Cardiovascular Dynamics, Inc.	LIT	Class II	1994-12-20
K943943	Transtibial Acl Disposables Kit	Arthrex GmbH	HRX	Class II	1994-12-20
K943782	Bone Screw Washer	Acu Med, Inc.	HTN	Class II	1994-12-20
K942562	Prosthoflex	Knopf Assoc, Inc.	EBI	Class II	1994-12-20
K942228	Orex o.r. Towel	Thantex Specialties, Inc.	KKX	Class II	1994-12-20
K942163	Winner Self-Taking Home Blood Pressure Kit	Winmed Instruments Mfg. Corp.	DXN	Class II	1994-12-20
K945650	Spiffy	Thames Valley Children'S Centre	INN	Class I	1994-12-19
K944895	Bausch & Lomb Premier 90 (Balafilcon a) Contact Lens	Bausch & Lomb Incorporated	LPL	Class II	1994-12-19
K944854	Sterisure Sterilization Wrap	Fiberweb North America, Inc.	FRG	Class II	1994-12-19
K944814	Corvac Plastic Blood Collection Tube	Sherwood Medical Co.	GIM	Class II	1994-12-19
K944731	Abbott Imx 2 Analyzer	Abbott Medical	JJI	Class I	1994-12-19
K944506	Axsym Digoxin	Abbott Medical	KXT	Class II	1994-12-19
K944285	Osteonics Series 7000 Total Knee Femoral Components	Osteonics Corp.	JWH	Class II	1994-12-19
K944275	Dispens-O-Disc Piperacillin 100 Mcg./tazobactam 10 Mcg.	Difco Laboratories, Inc.	JTN	Class II	1994-12-19
K944211	Immulite Progesterone	Siemens Healthcare Diagnostics Inc.	JLS	Class I	1994-12-19
K943839	Stermed Non-Chlorinated Powder Free Gloves	Steriltx (USA), Inc.	LYY	Class I	1994-12-19
K943549	Restoration Acetabular Cup	Osteonics Corp.	JDI	Class II	1994-12-19
K943523	Anterior Cervial Plating System	Smith & Nephew Richards, Inc.	KWQ	Class II	1994-12-19
K943522	The Prompt Guidwire	Cordis US Corp.	DQX	Class II	1994-12-19
K943317	Pathodx Respiratory Syncytial Virus (Rsv)	Siemens Healthcare Diagnostics Inc.	LKT	Class I	1994-12-19
K942935	Acutome 100 Color-Corrected CO2 Laser Handpiece	Reliant Technologies, Inc.	GEX	Class II	1994-12-19
K942384	Endurance R3000	Essential Medical Supply, Inc.	CAF	Class II	1994-12-19
K941650	Total Toe System II	Zimmer GmbH	LZJ	Unclassified	1994-12-19
K941595	Microject Model 200, Model 30, and Model Tpn-5	Microject, Inc.	FRN	Class II	1994-12-19