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 2221 of 3531

510(k) clearances, page 2221 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K936186	Aesculap Skin Graft Mesher	Aesculap Inc	FZW	Class I	1994-03-10
K936048	Lightwear(tm) Syst (Lightwear Headlight Clip/headband)	Cogent Light Technologies, Inc.	FST	Class II	1994-03-10
K935961	Gc Fuji Coat Lc	GC America Inc.	KLE	Class II	1994-03-10
K935929	Microtrack	Devices for Vascular Intervention, Inc.	MCW	Class II	1994-03-10
K935905	Scimed Entre Ptca Guide Wire with J-Tip	Scimed Life Systems, Inc.	DQX	Class II	1994-03-10
K935517	Snap Sternum Saw	Surgiquip, Inc.	HAB	Class I	1994-03-10
K934161	Proform Hip System	Globus Medical, Inc.	JDO	Class II	1994-03-10
K934044	Anterior Cruciate Ligament (Acl) Surgical Instrumentation System	Smith and Nephew Donjoy, Inc.	HWC	Class II	1994-03-10
K933526	Sterile Water	Trinity Laboratories, Inc.	JOL	Class II	1994-03-10
K932862	Rounded Cannulated Inside-Out (Rci) Acl Screw	Smith and Nephew Donjoy, Inc.	HWC	Class II	1994-03-10
K932593	Access to Synthes Ti-6A1-7Nb Unreamed Femoral Nail	Synthes (USA) Products LLC	HSB	Class II	1994-03-10
K932574	Rmhs Porous Distal Sleeve	Smith & Nephew Richards, Inc.	JDI	Class II	1994-03-10
K932519	Osteonics(r) Omnifit(r) Normalized Hip Stem	Osteonics Corp.	LZO	Class II	1994-03-10
K931732	Vifi: Vector Interferential One	Compliance Technology, Inc.	LIH	Class II	1994-03-10
K931588	Sutter Proximal Interphalangeal Joint	Sutter Corp.	KYJ	Class II	1994-03-10
K926395	Elite(tm) Zirconia Total Hip Ball Head System	Depuy, Inc.	LZO	Class II	1994-03-10
K925567	E 4000 Dental Operating Chair	Dentalez Group	KLC	Class I	1994-03-10
K925485	Vas-Cath Inc. Opti-Plast Angioplasty Catheter	Vas-Cath, Inc.	LIT	Class II	1994-03-10
K925460	Synthes Sterile Pinless External Fixator	Synthes (USA) Products LLC	KTT	Class II	1994-03-10
K925345	Ziconia Ceramic Mod Head(type I Taper 28/32, +6Mm)	Zimmer GmbH	LZO	Class II	1994-03-10
K922796	Pelvic C-Clamp	Synthes (USA) Products LLC	JEC	Class II	1994-03-10
K921805	Stryker Precision Dental Implant System	Stryker Corp.	DZE	Class II	1994-03-10
K940440	Dukal Non-Woven Gauze	Dukal Corp.	EFQ	Unclassified	1994-03-09
K940181	Se-Check	Streck Laboratories, Inc.	JPK	Class II	1994-03-09
K940171	Cabot Medical Niagra-Trs Thermal Retention System	Cabot Medical Corp.	DWJ	Class II	1994-03-09
K936216	Sterile Gauze Sponges	Dav-Mar Medical Products, Inc.	EFQ	Unclassified	1994-03-09
K935950	Fx-Cablelok Cable/plate System	Buckman Co., Inc.	JDQ	Class II	1994-03-09
K935646	Fx-Cablelok(tm) Stop(trochanter Hook) System	Biodynamic Technologies, Inc.	JDQ	Class II	1994-03-09
K935256	Patient Examination Gloves	Comfort Rubber Gloves Industries Sdn Bhd	LYY	Class I	1994-03-09
K935078	S-Rom Total Hip Replacement System	Joint Medical Products Corp.	JDG	Class II	1994-03-09
K934842	Tecnol Splashguard	Tecnol Medical Products, Inc.	LYU	Class I	1994-03-09
K934737	Lasso (Schwaitzberg) Suture Snare	Performance Surgical Instruments Corp.	GCJ	Class II	1994-03-09
K934174	Ligaclip Endoscopic Rotating Multiple Clip Applier	Ethicon, Inc	OCW	Class II	1994-03-09
K934162	Proform Ha Hip System	Globus Medical, Inc.	JDO	Class II	1994-03-09
K933810	Powder Free Latex Examination Gloves	Clydesdale Industries Sdn. Bhd.	LYY	Class I	1994-03-09
K933561	Osteonics Omnifit Forged Hip Stem Series	Osteonics Corp.	JDI	Class II	1994-03-09
K933383	Reagents for Hitachi Ise	Alko Diagnostic Corp.	JIX	Class II	1994-03-09
K933002	Erbotom Icc 350	Erbe USA Inc	GEI	Class II	1994-03-09
K932817	Hm-880 I	Hill-Med, Inc.	GEI	Class II	1994-03-09
K930756	Laparoscopic Irrigation/aspiration Handpiece	Endo Technic Corp.	HET	Class II	1994-03-09
K926543	Sharplan Nd:yag Surgical Laser, Model 3060 Sharplaser 60	Sharplan Lasers, Inc.	GEX	Class II	1994-03-09
K926156	Replica(tm) Total Hip System	Osteo Technology, Inc.	LPH	Class II	1994-03-09
K924485	Laparoscopy Set	Owens Precision Systems, Inc.	HET	Class II	1994-03-09
K924258	Megabeam Radial Emit Shape Fiber Optic Deliv Syst	Ceram Optec, Inc.	GEX	Class II	1994-03-09
K922110	Go-Clean	Viva-Tek Assoc., Inc.	FRR	Class II	1994-03-09
K914524	Fluid Pump, Cp #3	United States Endoscopy Group, Inc.	FEB	Class II	1994-03-09
K940444	General Surgery Tray	Cush Medical Products	LRP	Class I	1994-03-07
K940435	Aurolite 54+2	Argen Precious Metals, Inc.	EJT	Class II	1994-03-07
K940434	Aurolite 2B	Argen Precious Metals, Inc.	EJT	Class II	1994-03-07
K940361	Aurolite 1C	Argen Precious Metals, Inc.	EJT	Class II	1994-03-07