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 1836 of 3531

510(k) clearances, page 1836 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980053	Glenroe Chain	Glenroe Technologies	ECI	Class I	1998-02-24
K980051	Palfique Estelite Paste	Tokuyama America Inc.	EBF	Class II	1998-02-24
K974909	Synermed Creatinine Reagent Kit	Synermed Intl., Inc.	CGX	Class II	1998-02-24
K974784	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	CEM	Class II	1998-02-24
K974782	Low Protein Powder Free Latex Examination Gloves	Mexpo Intl., Inc.	LYY	Class I	1998-02-24
K974727	Jet Acrylic Liquid-Monomer, Ortho Jet Powder-Polymer, Plasticized Methacrylate Homopolymer, Methacrylate Copolymer, Metr	J.B.C and Co.	EBI	Class II	1998-02-24
K974654	Silicone Blocks	Specialty Surgical Products, Inc.	MIB	Class II	1998-02-24
K974566	Mda Simplastin Htf	bioMerieux, Inc.	GJS	Class II	1998-02-24
K974554	Synthes Resorbable Fixation System	Synthes (USA) Products LLC	JEY	Class II	1998-02-24
K974485	Sauflon All-in-One Light Contact Lens Solution	Szabocsik and Assoc.	LPN	Class II	1998-02-24
K974482	Silimed Gluteal Implant	Silimed, LLC	MIB	Class II	1998-02-24
K974480	Silimed Calf Implant	Silimed, LLC	MIB	Class II	1998-02-24
K974474	Pegasys Intouch	Philips North America LLC	LLZ	Class II	1998-02-24
K974469	Mentor Phacoemulsification Sistem Remote Control	Mentor	HQC	Class II	1998-02-24
K974180	Steri-Tamp	Pharmacy, Inc.	KPE	Class II	1998-02-24
K973900	Testoterone Elisa	Kmi Diagnostics, Inc.	CDZ	Class I	1998-02-24
K973700	Hermes Operating Room Control Center	Computer Motion, Inc.	GCJ	Class II	1998-02-24
K973326	Quikpac II One Step Benzodiazepine Test	Drial Consultants, Inc.	JXM	Class II	1998-02-24
K972798	Dynemo 3000	Sometec, Inc.	DPW	Class II	1998-02-24
K972145	Hep-2000 Fluorescent Ana-Ro Test System	IMMUNO CONCEPTS, NA, Ltd.	DHN	Class II	1998-02-24
K972075	Vacutainer Brand Ppt Plasma Preparation Tube	Becton Dickinson Vacutainer Systems	PJE	Class II	1998-02-24
K974578	Grepafloxacin, 5 Mg, Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1998-02-23
K974559	Scimed 6 French Impulse Angiographic Catheters	Scimed Life Systems, Inc.	DQO	Class II	1998-02-23
K974401	4.0Mm Simpler One Threaded Dental Implant	Vancouver Implant Resources, Inc.	DZE	Class II	1998-02-23
K973829	Irrigation Bottle	Automatic Liquid Packaging, Inc.	JOH	Class II	1998-02-23
K973080	Surgical Vascular Clamp	Biomet Microfixation	DXC	Class II	1998-02-23
K972814	Locator Model 4036	Pacesetter, Inc.	DTB	Class III	1998-02-23
K972676	Urine Screening Device	Combact Diagnostic Systems, Ltd.	JXA	Class I	1998-02-23
K972207	Medcomp Ash Split-Cath 28Cm, Medcomp Ash Split-Cath 32Cm	Medcomp	MSD	Class II	1998-02-23
K971925	Medcomp Bio-Flex Cs Catheter (Cs100)	Medical Components, Inc.	MSD	Class II	1998-02-23
K980209	Simplicare Thin Film Wound Dressings	Hollister, Inc.	MGP	Unclassified	1998-02-20
K974823	Nonwoven Dressing	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1998-02-20
K974816	Access(r) Psa Reagents on the Access(r) Immunoassay Analyzer 33220, 33225, 33229	Beckman Instruments, Inc.	LTJ	Class II	1998-02-20
K974521	Vnus Closure System	Vnus Medical Technologies, Inc.	GEI	Class II	1998-02-20
K974455	Anatom 1000 (a Minus, a-)	Analogic Corp.	JAK	Class II	1998-02-20
K974433	Chromophare D 500, Chromophare D 530	Berchtold Holding GmbH	FSY	Class II	1998-02-20
K974280	Abutment - Complete	Implant Center of the Palm Beaches	DZE	Class II	1998-02-20
K974219	Faceplate Assembly	Finetone Hearing Instruments	LRB	Class I	1998-02-20
K973169	Pressure Guard Site Select (a)	Span-America Medical Systems, Inc.	FNM	Class II	1998-02-20
K972904	Document Molecular Pathology Chlamydia Trachomatis Control	Casco Standards	JJY	Class I	1998-02-20
K972795	Cardio-Card Management System II	Nasiff Assoc., Inc.	DXN	Class II	1998-02-20
K972486	Pressureguard IV	Span-America Medical Systems, Inc.	IKZ	Class II	1998-02-20
K972158	Go Medical Patient Controlled Analgesia Devices	Princeton Regulatory Assoc.	MEB	Class II	1998-02-20
K963759	Dideco Compact-a and Compact-M Autotransfusion Systems	Sorin Biomedical, Inc.	CAC	Class II	1998-02-20
K963758	Code 150 Blood Component Collection Set and with Direct Draw Line	Sorin Biomedical, Inc.	CAC	Class II	1998-02-20
K980107	Runch Industrial Wheelchair	Runch Group USA, Inc.	IOR	Class I	1998-02-19
K974775	Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure Gauge	Airtronic Services, Inc.	FAP	Class II	1998-02-19
K974684	Scimed 7 French Wiseguide Guide Catheter	Scimed Life Systems, Inc.	DQY	Class II	1998-02-19
K974561	Moistair Fluid Air Tubing Set	American Medical Devices, Inc.	KYG	Class I	1998-02-19
K974467	Aesculap-Meditec Slit Lamps Sl07 and Sl08	Aesculap-Meditec North America	HJO	Class II	1998-02-19