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 2148 of 3531

510(k) clearances, page 2148 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940713	Pca Modular Primary/revision Patella	Howmedica Corp.	JWH	Class II	1994-11-10
K940319	R-Group International Coiled Low Pressure Extension Line	R-Group Intl.	FPA	Class II	1994-11-10
K940014	Plm Sensor, Model Plm1	Pro-Tech, Inc.	BZQ	Class II	1994-11-10
K935979	Continuous Positive Airway Pressure CPAP System	Devilbiss Health Care, Inc.	BZD	Class II	1994-11-10
K935839	Gemscom Series 5000,	General Devices	DRG	Class II	1994-11-10
K935162	Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit	Helena Laboratories, Corp.	JHO	Class I	1994-11-10
K933947	Lifecare CPAP-200	Lifecare International,Inc.	BZD	Class II	1994-11-10
K931072	Hgm Illuminating/aspirating Endoocular Probe	Hgm, Inc.	HJM	Class II	1994-11-10
K945299	Disposable & Reusable Chuck Handle	Boston Surgical Products, Inc.	GEI	Class II	1994-11-09
K945260	E3590, Smoke Evacuation Attchment for Electrosurgical Pencils	Medtronic, Inc.	GEI	Class II	1994-11-09
K945133	Modified Biopsy Needle	Biopsys Medical, Inc.	FCG	Class II	1994-11-09
K945101	Karl Storz Retractors, Probes, Dissectors, Hookd	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-11-09
K945059	Karl Storz Suction/irrigation Tubes. Cannulae, Sheaths	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-11-09
K944955	Aesculap Thoracoscopic Instruments	Aesculap Inc	KNS	Class II	1994-11-09
K944817	Neutralect Adult Standard, Return (Rem), Paediatric Standard, Return (Rem)	Msb, Ltd.	GEI	Class II	1994-11-09
K944630	Model 230-Sas Laser Delivery Probe	Mnlase, Inc.	GEX	Class II	1994-11-09
K944413	Acm PTFE Surgical Mesh	American Custom Medical, Inc.	FTL	Class II	1994-11-09
K944408	Implantech Medical Grade Silicone Sheeting	King & Spalding	MIB	Class II	1994-11-09
K944153	Eclipse 3200	Cardiogenes	GEX	Class II	1994-11-09
K943875	Villalta Retractor	Hct, Inc.	GAD	Class I	1994-11-09
K942603	Orthopaedic Wires	Acu Med, Inc.	LRN	Class II	1994-11-09
K942095	Sonoca III	Holl Meditronics, Inc.	LFL	Unclassified	1994-11-09
K942081	Envision Arthroscopy System	Envision Surgical System, Inc.	HRX	Class II	1994-11-09
K941193	East West Instruments	East West Instruments, Inc.	MDM	Class I	1994-11-09
K930821	Thera-Fit	Aquatherapy Systems, Inc.	ILJ	Class II	1994-11-09
K930820	Aquadyne	Aquatherapy Systems, Inc.	ILJ	Class II	1994-11-09
K945440	Disposable, Anesthesia/respiratory Face Mask	Fvtnks	BSJ	Class I	1994-11-08
K944977	Coaxial Endostat	Laserscope	GEX	Class II	1994-11-08
K944974	Access Point	Access Surgical Intl., Inc.	GCJ	Class II	1994-11-08
K944954	Endoscopic Reposable Tip Surgical Instruments	United Fortune International, Inc.	GCJ	Class II	1994-11-08
K944897	Home Care Ear Examinatio Kit	Home Care Instruments, Inc.	ERA	Class I	1994-11-08
K944818	Cook Aspiration/irrigation Unit	Cook Incorporated	BTA	Class II	1994-11-08
K944654	Oxygen Concentration Indicator	Aequitron Medical, Inc.	CCL	Class II	1994-11-08
K944346	Lasersonics Radiance Diode Laser Systems and Accessories	Heraeus Surgical, Inc.	GEX	Class II	1994-11-08
K943789	Power Wheelchair Conversion Kit	Alber Technologies, Inc.	ITI	Class II	1994-11-08
K943592	Chemstrip Mini Ua Urine Analyzer	Boehringer Mannheim Corp.	KQO	Class I	1994-11-08
K940960	Suction and Irrigation Tubes	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-11-08
K935586	Prince	Instromedix, Inc.	DXH	Class II	1994-11-08
K934756	Codman Anterior Cervical Spine Plate System	Cerenovus, Inc.	KWQ	Class II	1994-11-08
K934556	Ems-250	Electronic Medical Sciences, Inc.	IPF	Class II	1994-11-08
K933976	Mandelkorn Suture Lysis Lens	Ocular Instruments, Inc.	HJK	Class II	1994-11-08
K933539	Foundation Posterior Stabilized Knee	Encore Orthopedics, Inc.	JWH	Class II	1994-11-08
K945269	Optus Laryngoscopes	Optus, Inc.	CCW	Class I	1994-11-07
K944939	Celebrity Xl Sc445	Pride Health Care, Inc.	INI	Class II	1994-11-07
K944888	Medalist	J.F. Jelenko & Co., Inc.	EJT	Class II	1994-11-07
K944887	Eureka Plus	J.F. Jelenko & Co., Inc.	EJT	Class II	1994-11-07
K944679	Jel 96	J.F. Jelenko & Co., Inc.	EJT	Class II	1994-11-07
K944588	Sterile Plastic Dressing	Smith & Nephew, Inc.	KGX	Class I	1994-11-07
K944552	Pilling Weck M-20 Disposable Automatic Hemoclip	Pilling Weck, Inc.	FZP	Class II	1994-11-07
K944230	Dial Medical Supply Sharps Container	Regulatory & Marketing Services, Inc.	FMI	Class II	1994-11-07