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 2202 of 3531

510(k) clearances, page 2202 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941375	Conquest Ginga-Blend	Jeneric/Pentron, Inc.	EBF	Class II	1994-05-02
K941374	Conquest Prelude	Jeneric/Pentron, Inc.	EBF	Class II	1994-05-02
K941301	Roll a Bout Walker	Roll A Bout Corp.	IOR	Class I	1994-05-02
K941245	Poly-Medics Heat Pack	Zimmer GmbH	IMD	Class I	1994-05-02
K941132	Liquid Ast (Sgot)reagent Set	Horiba Instruments Incorporated	CIT	Class II	1994-05-02
K940844	Myoma Drill 5Mm-8383.611	Richard Wolf Medical Instruments Corp.	HET	Class II	1994-05-02
K940763	Isolyser (8X4 12 Ply X-Ray Detectable)	Thantex Specialties, Inc.	GDY	Class I	1994-05-02
K940762	Isolyser (18X18 X-Ray Detectable)	Thantex Specialties, Inc.	GDY	Class I	1994-05-02
K940757	Isolyser (4X18) X-Ray Detectable	Thantex Specialties, Inc.	GDY	Class I	1994-05-02
K940756	Isolyser (X-Ray Detectable)	Thantex Specialties, Inc.	GDY	Class I	1994-05-02
K940755	Isolyer (4X4, 8Ply)	Isolyer Co.	NAB	Class I	1994-05-02
K940754	Isolyer (4X4, 12 Ply)	Thantex Specialties, Inc.	EFQ	Unclassified	1994-05-02
K940299	Electrosurgical Dispersive Electrode and Electrosurgical Dual Return Electrode with Conductive Gel and 10 Ft. Cord	Debusk Technology Corp.	GEI	Class II	1994-05-02
K940253	Histone Eia Test Kit	David A. Fuccillo, Ph.D.	LJM	Class II	1994-05-02
K940244	Verident Plus, Optiform	Lactona Corp.	ELM	Class II	1994-05-02
K940205	Peri-Strips	Bio-Vascular, Inc.	FTM	Class II	1994-05-02
K940122	Hy Bond, Glasionomer Cx	Shofu Dental Corp.	EMA	Class II	1994-05-02
K940062	Diastat Vascular Access Graft	W. L. Gore & Associates, Inc.	DSY	Class II	1994-05-02
K940058	Monoject Blood Collection Tubes W/safety Stopper	Sherwood Medical Co.	GIM	Class II	1994-05-02
K940019	Gabriel Ureteral Illuminator System	Gabriel Medical, Inc.	FCS	Class II	1994-05-02
K936023	Sysmex Se-9000 Automated Hematology Analyzer	Toa Medical Electronics USA, Inc.	GKZ	Class II	1994-05-02
K935980	Cir Latex Gloves (Cir Gold Seal)	Crocker Industrial Resources Sdn. Bhd.	LYY	Class I	1994-05-02
K935754	Murdoch Intraoperative Laparoscopic Lens Cleaner	Cook Incorporated	GCJ	Class II	1994-05-02
K935697	Circumcision Tray	Cush Medical Products	HFX	Class II	1994-05-02
K935416	Ro Eia Test Kit	David A. Fuccillo, Ph.D.	LJM	Class II	1994-05-02
K935415	Rnp Eia Test Kit	David A. Fuccillo, Ph.D.	LJM	Class II	1994-05-02
K935414	Sm Eia Test Kit	David A. Fuccillo, Ph.D.	LJM	Class II	1994-05-02
K935245	Epidural Anesthesia Tray	Spinal Specialties, Inc.	CAZ	Class II	1994-05-02
K934976	Instavac II	Aeros Instruments, Inc.	BTA	Class II	1994-05-02
K934482	Vital Signs Dual Display Temperature Monitor, Model 1600	Vital Signs, Inc.	FLL	Class II	1994-05-02
K933055	Medtronis(r) Pacing Leads and Lead Adaptors, Modif	Medtronic, Inc.	DTB	Class III	1994-05-02
K932981	Coherent Versapulse 2.1 Holmium Surgical Lasers	Coherent Medical Group	GEX	Class II	1994-05-02
K932938	Elmed Esu 300 M/m and Digital	Elmed, Inc.	GEI	Class II	1994-05-02
K932884	Minix/minix St Pulse Generators	Medtronic, Inc.	DXY	Class III	1994-05-02
K932464	Peripherallyinsrted Venous Cath. Alternate Cath.	Pharmacia Deltec, Inc.	LJS	Class II	1994-05-02
K932433	Pheripherally Inserted Venous Catheter-Y Site	Pharmacia Deltec, Inc.	LJS	Class II	1994-05-02
K932430	Dual Lumen Peripherally Inserted Venous Catheter	Pharmacia Deltec, Inc.	LJS	Class II	1994-05-02
K932283	Patient Examination Gloves	Eac Rubber Industries (M) Sdn. Bhd.	LYY	Class I	1994-05-02
K932211	Procedural Tray for Peripherally Inserted Venous	Pharmacia Deltec, Inc.	LJS	Class II	1994-05-02
K932198	Pharmacia Deltec Peripherally Inserted Venous Cath	Pharmacia Deltec, Inc.	LJS	Class II	1994-05-02
K931580	Disposable Surgical Mask (Modified)	Bam Corp., Ltd.	FXX	Class II	1994-05-02
K931420	Coatest(r) Antithrombin III, Modification	Kabi Pharmacia Hepar, Inc.	JBQ	Class II	1994-05-02
K931225	Low Profile Mid Cross Bracing	Advanced Spine Fixation Systems, Inc.	KWP	Class II	1994-05-02
K926448	i.v. Administration Set	Gainor Medical Europe, Ltd.	FPA	Class II	1994-05-02
K925854	Vygon - Enteral Feeding Tube - Polyurethane	Vygon Corp.	KNT	Class II	1994-05-02
K925483	Branemark Syst. Hand Inst. Dia 297 & Sdia 276	Nobelpharma USA, Inc.	DZE	Class II	1994-05-02
K921722	Bard(r) Leventhal(tm) Gyne-Flo(tm) Cannula	Bard Reproductive Systems	HET	Class II	1994-05-02
K921652	Mic Transgastric Jejunal Feeding Tube Kit	Medical Innovations, Inc.	KNT	Class II	1994-05-02
K921370	Mic Gastro-Enterostomy Tube Modification	Medical Innovations, Inc.	KNT	Class II	1994-05-02
K912325	Micro-Pap(tm) Kit	Micro-Pap Corp.	HHT	Class II	1994-05-02