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 2001 of 3531

510(k) clearances, page 2001 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925872	Northo Bone Screw	Northo Orthopedics	HWC	Class II	1996-03-22
K960808	Conmed Select One Laparoscopy Electrode	Conmedcorp	GEI	Class II	1996-03-21
K960661	Maxcess Needle Free Connector (8200)	Solopak Medical Products, Inc.	FPA	Class II	1996-03-21
K960602	Ssa-340A (Modification)	Toshiba America Medical Systems, In.C	IYN	Class II	1996-03-21
K960520	Laceration Tray	Medco Instruments, Inc.	FRG	Class II	1996-03-21
K960428	Carrasyn Hydrogel Wound Dressing/fdg Pads/caragauze Strips/pads (Modification)	Carrington Laboratories, Inc.	MGQ	Unclassified	1996-03-21
K960426	Medicomp Flexi-Smooth Wound Drainage Catheter	Medical Components, Inc.	GBW	Class I	1996-03-21
K960232	Endoscopic Access Device	Applied Medical Technologies	GCJ	Class II	1996-03-21
K960082	Discography Kit	Spinal Specialties, Inc.	IZG	Class II	1996-03-21
K955838	Atrisorb Bioabsorbable Guided Tissue Regneration(gtr)	Atrix Laboratories, Inc.	NPK	Class II	1996-03-21
K955819	A2 Detached Dual Port System	Arrow Intl., Inc.	LJT	Class II	1996-03-21
K955805	Dual Spray Minispacer	Thayer Medical Corportation	CAF	Class II	1996-03-21
K955790	Pap Plus Speculoscopy Comprehensive Pelvic Exam Tray	Trylon Corp.	HIC	Class II	1996-03-21
K955789	Alcon Series 20000 Legacy Mackool System	Alcon Laboratories	HQC	Class II	1996-03-21
K955587	Vascular Access Port Kit	Boston Scientific Corporation	LJT	Class II	1996-03-21
K955411	Delta 16	Instrumentarium Imaging, Inc.	IZH	Class II	1996-03-21
K954338	Innovasive 1.9Mm Roc Suture Bone Fastener	Innovasive Devices, Inc.	MBI	Class II	1996-03-21
K951832	Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433	Vasamedics, LLC	DPT	Class II	1996-03-21
K951579	Ec-3800Tl, Video Colonoscope	Pentax Precision Instrument Corp.	FDF	Class II	1996-03-21
K951577	Es-3800, Video Sigmoidoscope	Pentax Precision Instrument Corp.	FAM	Class II	1996-03-21
K951574	Ec-3800L, Video Colonoscope	Pentax Precision Instrument Corp.	FDF	Class II	1996-03-21
K946168	Ivac Enteral Admin. Sets, Ivac Infusion Pumps	Ivac Corporation	LZH	Class II	1996-03-21
K960883	Intraducer Peritoneal Catheter 6Frx3, 9Frx3 1/2, 10Frx4, 12Frx8	Taut, Inc.	GCJ	Class II	1996-03-20
K960852	Hall Modular Acetabular Reamer System	Linvatec Corporation	HWE	Class I	1996-03-20
K960471	Tri-Count 20	Hematronix, Inc.	JPK	Class II	1996-03-20
K960362	Permamesh Hydroxylapatite Matrix	Ceramed Corp.	LZK	Class II	1996-03-20
K960354	Permamesh-D Hydroxylapatite Matrix	Ceramed Corp.	LZK	Class II	1996-03-20
K960182	Dsdna Immunoglobulin Eia Test System	Mardx Diagnostics, Inc.	LRM	Class II	1996-03-20
K960110	Kis Mt3	Implant Center of the Palm Beaches	DZE	Class II	1996-03-20
K960091	Enzyme Immunoassay Anti-Double Stranded DNA (Dsdna) Test Kit	Helix Diagnostics, Inc.	LRM	Class II	1996-03-20
K960004	Cell Recovery System	Medical Device Technologies, Inc.	FDX	Class II	1996-03-20
K955848	Orthofix Modulsystem	Orthofix SRL	JDW	Class II	1996-03-20
K955822	Removable Herbst Appliance	Univ. Dental Assoc. Department of Orthodontics	LRK	Class II	1996-03-20
K955629	Lxn Fructosamine Test	Lxn Corp.	JJX	Class I	1996-03-20
K955164	S.a.r.s. II (Semi-Automatic-Reconstituting-System)	Habley Medical Technology Corp.	FMF	Class II	1996-03-20
K955134	Orgentec Enascreen Elisa Assay	Orgentec	LLL	Class II	1996-03-20
K955133	Orgentec Enascreen Pin Immuno Assay	Orgentec	LLL	Class II	1996-03-20
K954895	Hytec Autoimmune Kit (Jo-1)	Hycor Biomedical	LLL	Class II	1996-03-20
K954894	Hytec Autoimmune Kits (Scl-70)	Hycor Biomedical	LLL	Class II	1996-03-20
K954893	Hytec Automimmune Kit (Ds-DNA)	Hycor Biomedical	LRM	Class II	1996-03-20
K953896	The Imed Ambulatory Infusion Pump, Administration Sets	Imed Corp.	FRN	Class II	1996-03-20
K953865	Spaceline Feel 21	J. Morita USA, Inc.	EFA	Class I	1996-03-20
K953414	CPR Micromask with Oxygen Inlet	Plasco, Inc.	CBP	Class II	1996-03-20
K951903	Epix Xl TENS Unit	Empi	GZJ	Class II	1996-03-20
K951799	Varicella-Zoster Virus Direct Immunofluorescence Assay	Light Diagnostics	GQX	Class II	1996-03-20
K960650	Non Prescription Sun Glasses	Solovision Optical, Inc.	HQY	Class I	1996-03-19
K960436	Selfcare Early Pregnancy Test	Selfcare, Inc.	LCX	Class II	1996-03-19
K960412	T-3 Microwell Eia Model 7013	Biomerica	CDP	Class II	1996-03-19
K960298	Vivaspin 4 10,000 Mw	Vivascience, Inc.	JJH	Class I	1996-03-19
K960117	Platform Onestep Pregnancy Home Test	Syntron Bioresearch, Inc.	LCX	Class II	1996-03-19