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 2245 of 3531

510(k) clearances, page 2245 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932261	Es-100 Accessories	Elekta Instruments, Inc.	HWE	Class I	1994-01-07
K932048	Silicone Gel Sheeting	Silipos, Inc.	MDA	Class I	1994-01-07
K932038	Suture Nonabsorbable- Silk, Polyester	Surgical Specialties Corp	GAT	Class II	1994-01-07
K932037	Suture Absorbable- Gut	Surgical Specialties Corp	GAR	Class II	1994-01-07
K931837	Acufex Sterile Drills	Acufex Microsurgical, Inc.	HWE	Class I	1994-01-07
K931737	Hedleyl Intramedullary Preparation Brush	Synvasive Technology, Inc.	HTZ	Class I	1994-01-07
K931659	3 Lead Connector	Douglas Medical Products, Inc	FPA	Class II	1994-01-07
K931305	Eclipse 3200 for Use in Urology Applications	Cardiogenes	GEX	Class II	1994-01-07
K931271	Ethi-Pack* Surgical Stainless Steel Suture	Ethicon, Inc	GAQ	Class II	1994-01-07
K930970	Baumer Screws	Baumer Ortopedia, Ltd.	HWC	Class II	1994-01-07
K930963	Sl-Plus & Slr-Plus Stems W/biolox Ceramic Heads	Encore Orthopedics, Inc.	LZO	Class II	1994-01-07
K930892	Mitek Mini Anchor, Modification	Mitek Surgical Products, Inc.	JDR	Class II	1994-01-07
K930826	Suture Nonabsorbable - Silk	Surgical Specialties Corp	GAP	Class II	1994-01-07
K930825	Suture Nonabsorbable-Nylon,silk,polyester,stainles	Surgical Specialties Corp	GAP	Class II	1994-01-07
K930772	Ethicon* Monocryl (Poliglecaprone 25) Suture	Ethicon, Inc	GAM	Class II	1994-01-07
K930588	Dexon S, Dexon Plus, and Dexon II Polycolic Acid	Davis & Geck, Inc.	GAM	Class II	1994-01-07
K930363	Powered Surgical Instrument Accessory	Intenn Engineering, Inc.	HWE	Class I	1994-01-07
K930319	Osteon Adaptor/cradle	United American Medical Co., Inc.	HWE	Class I	1994-01-07
K930248	Vinyl Polysiloxane 2 Component Vulcanizing System	Crown Delta Corp.	ELW	Class II	1994-01-07
K925837	Amk Landmark Revision Knee Full Wedge Tibial Tray	Depuy, Inc.	JWH	Class II	1994-01-07
K925682	Biopro Ziralloy Modular Femoral Heads, Modified	Biopro, Inc.	LZO	Class II	1994-01-07
K925536	Hybrid Femoral Stem, Perfecta Total Hip System	Orthomet, Inc.	KWY	Class II	1994-01-07
K923514	Clarus Series 2100 Endoscope	Clarus Medical Systems, Inc.	HRX	Class II	1994-01-07
K923243	Perfecta Total Hip System	Orthomet, Inc.	JDI	Class II	1994-01-07
K922500	Psl Total Hip Replacement System	Biopro, Inc.	LPH	Class II	1994-01-07
K921382	Futura Texture-Trakked Total Hip Stem	Arthronics, Inc.	LWJ	Class II	1994-01-07
K915844	Exact-Touch	Baal Assoc., Inc.	HHT	Class II	1994-01-07
K915612	Argenco Y +	Argen Precious Metals, Inc.	EJT	Class II	1994-01-07
K935541	Sunglasses	Seven Pyramid Ent Co., Ltd.	HQY	Class I	1994-01-06
K935521	Gc Elite Cement	GC America Inc.	EMA	Class II	1994-01-06
K935388	Cerapall 4Cf	Metalor	EJS	Class II	1994-01-06
K935387	Pontor Lfc	Metalor	EJT	Class II	1994-01-06
K935165	Biker Mice Sunglasses	Ja-Ru, Inc.	HQY	Class I	1994-01-06
K935117	Emit(r) Iic Opiate Assay	Syva Co.	DJG	Class II	1994-01-06
K934821	Cprotector	Certified Safety Mfg Inc	CBP	Class II	1994-01-06
K934746	3M Curing Light Xl1500	3M Company	EBZ	Class II	1994-01-06
K934020	Sunglasses	Sun Probe Enterprise Co., Ltd.	HQY	Class I	1994-01-06
K933938	Fine Optics Sunglasses	Fine Optics, Inc.	HQY	Class I	1994-01-06
K933790	5Mm Disposable Suction-Irrigation Cannula	Phx Technologies Corp.	GCJ	Class II	1994-01-06
K933789	10Mm Disposable, Sterile Suction Cannula	Phx Technologies Corp.	GCJ	Class II	1994-01-06
K933503	Pro-Phaco Handpiece	M. Imonti and Associates Inc.	HQC	Class II	1994-01-06
K933235	Cordis Bipal 7 /Biopsy & Bipal Biopsy Forceps, Modif	Cordis US Corp.	DWZ	Class II	1994-01-06
K933199	Crystalline 'Fluorite' Core Build-Up Material	Confi-Dental Products Co.	EMA	Class II	1994-01-06
K932878	Precision Intra-Oral Scopes	Precise Optics	EIA	Class I	1994-01-06
K932469	Visual Scene Sunglasses	Vsi Intl., Inc.	HQY	Class I	1994-01-06
K932214	Silon Silicone Gel Sheet	Bio Med Sciences, Inc.	MDA	Class I	1994-01-06
K930790	Addition of Built-in Oxymeter to Sleepscan Prod.	Bio-Logic Systems Corp.	BZQ	Class II	1994-01-06
K930195	Ophthalmic Trial Lenses	Optimark Accessories and Instruments	HPC	Class I	1994-01-06
K925869	Sheathes, Sterile Sheathes	Mayer Laboratories	ITX	Class II	1994-01-06
K925798	A-Dec 2545 Duo Ic Micro-Cart	A-dec, Inc.	EIA	Class I	1994-01-06