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 1488 of 3531

510(k) clearances, page 1488 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K024316	Nim-Prs	Medtronic Xomed, Inc.	IKN	Class II	2003-01-06
K024154	Shanghai Huamao Powder-Free Yellow Vinyl Exam Gloves	Shanghai Huamao Gloves Co., Ltd.	LYZ	Class I	2003-01-06
K024048	Modification to Boston Scientific Express Biliary Ld Premounted Stent System	Boston Scientific Corporation	FGE	Class II	2003-01-06
K023592	Seraquest Anti-Thyroglobulin	Quest Intl., Inc.	DDC	Class II	2003-01-06
K023410	Validate Chem 10 Calibration Verification Test Set, Model 110	Maine Standards Co.	JJY	Class I	2003-01-06
K020924	Custodiol Htk Solution	Dr. Franz Kohler Chemie GmbH	KDL	Class II	2003-01-06
K024197	Lifedop Doppler	Summit Doppler Systems, Inc.	KNG	Class II	2003-01-03
K024196	Reeads Anti-Phosphatidylserine Igg/igm Semi-Quantitative Test Kit	Corgenix, Inc.	MID	Class II	2003-01-03
K024195	Modification to Reaads Anti-Phosphatidylserine Iga Semi-Quantative Test Kit	Corgenix, Inc.	MID	Class II	2003-01-03
K024002	Pentra 80	Horiba Instruments Incorporated	GKZ	Class II	2003-01-03
K023744	Wiener Lab. Ck-Mb Ds UV Unitest, Model 28 X 2.5 Ml Cat. Nr. 1271354	Wiener Laboratories Saic	JHW	Class II	2003-01-03
K023638	Cassette/urine Hcg	Ind Diagnostic, Inc.	LCX	Class II	2003-01-03
K023599	Immunocard Stat! E. Coli O157 Plus	Meridian Bioscience Inc	GMZ	Class I	2003-01-03
K023373	Onepass Nuclear Imaging System, Model 70-500101	Gvi Technology Partners	IYX	Class I	2003-01-03
K023358	USA Series Dur 8 Elite, USA Series Dur 8, Models Dur 8E, Dur 8	Acmi Corporation	FGB	Class II	2003-01-03
K023346	Trophypan	Trophy Radiologie	MUH	Class II	2003-01-03
K023135	Image3 Se Disposable Full Face Mask	Respironics, Inc.	CBK	Class II	2003-01-03
K022521	Bicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 Gallon	Rockwell Medical	KPO	Class II	2003-01-03
K022126	Catheter Introducer for the Stealthstation System	Medtronic Navigation, Inc	HAW	Class II	2003-01-03
K024088	Ceralas D 980 Laser System with Endo Laser Vein System Kit, Model: D15 and D25	Biolitec, Inc.	GEX	Class II	2003-01-02
K021994	Bard Conformexx Biliary Stent and Delivery System	C.R. Bard Inc	FGE	Class II	2003-01-02
K021490	Reevue Indirect Calorimeter, Model#8100	Korr Medical Technologies, Inc.	BZL	Class II	2003-01-02
K020745	Cosmed Microquark	Cosmed S.r.l.	BTY	Class II	2003-01-02
K024084	Abbott Plum a+ Infusion Pump, Model 12391	Abbott Medical	FRN	Class II	2002-12-31
K023633	Sovis Optique's Endoscopic Cable	Sovis Optique	FFS	Class II	2002-12-31
K023334	Bmc Catheter Connector Cable, Model Rfp-101	Baylis Medical Co., Inc.	DSA	Class II	2002-12-31
K022466	Profile 1320 Laser System	Sciton, Inc.	GEX	Class II	2002-12-31
K022249	Nightron Polysomnography System	Telediagnostic Systems, Inc.	OLV	Class II	2002-12-31
K024130	Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile	WRP Asia Pacific Sdn Bhd	KGO	Class I	2002-12-30
K024109	Bd Ultra-Fine III Pen Needle	Becton Dickinson & Co	FMI	Class II	2002-12-30
K024058	Modification to Cardeon Aegis Catheter	Cardeon Corp.	DWF	Class II	2002-12-30
K024037	Narrow Ascent Interlok Femoral Components	Zimmer GmbH	JWH	Class II	2002-12-30
K024035	Attain 6218A-Am Amplatz Guide Catheter for Left-Heart Delivery	Medtronic, Inc.	DQY	Class II	2002-12-30
K024032	Attain 6216A-Mp Multi-Purpose Guide Catheter for Left-Heart Delivery	Medtronic, Inc.	DQY	Class II	2002-12-30
K023769	Prepare Administration Set	Appro Healthcare, Inc.	FPA	Class II	2002-12-30
K023656	Sickle-Chex Solubility Kit	Streck Laboratories, Inc.	GHM	Class II	2002-12-30
K023545	Ultra-Lite 200E Light Cure Unit	Rolence Ent. Inc.	EBZ	Class II	2002-12-30
K022854	Acell Ubm Hydrated Wound Dressing	Acell, Inc.	KGN	Unclassified	2002-12-30
K022584	Cardiotech Antibotic Hydrogel Wound Dressing	Cardiotech Intl.	MGQ	Unclassified	2002-12-30
K022091	Baldur Brand Vinyl Powder-Free Examination Gloves	Tangshan Zhonghong Pulin Group Co., Ltd.	LYZ	Class I	2002-12-30
K022009	3I Implants; Osseotite Dental Implants; Osseotite Nt Dental Implants	ZimVie US Corp LLC	DZE	Class II	2002-12-30
K020020	The Izzzy-TENS (Wl-2401), the Slim-TENS (Wl-2402), the Mens-TENS (Wl2403), the Compact TENS (Wl-2302)	Well-Life Healthcare Limited	GZJ	Class II	2002-12-30
K010185	6.0 X 5.7Mm Dental Implant	Bicon, LLC	DZE	Class II	2002-12-30
K023993	Galaxy Series Wheelchair	Evermed, Inc.	IOR	Class I	2002-12-27
K023388	Mitek Rapidloc-Pds Meniscal Repair System	Mitek Worldwide	JDR	Class II	2002-12-27
K023372	Non-Bioabsorbable Staple	Onux Medical, Inc.	NJU	Class II	2002-12-27
K021987	Parcomplast Compensating Filter for Radiation Therapy	S&S Par Scientific	IXI	Class II	2002-12-27
K023807	Modification to Alkp	Abbott Medical	CJE	Class II	2002-12-26
K023305	Kegelmaster 2000	Kegelmaster 2000, Ltd.	HIR	Class II	2002-12-26
K023259	Inhealth Soft Sleeve Colonoscope Splint, Model Cs1200	Freudenberg Medical, LLC	FDF	Class II	2002-12-26