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 2150 of 3531

510(k) clearances, page 2150 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945030	Surgi-Link Laparoscopic Electrodes	Unimed Surgical Products, Inc.	GEI	Class II	1994-11-03
K944629	Model 230-Sac Laser Delivery Probe	Mnlase, Inc.	GEX	Class II	1994-11-03
K944628	Model 220-Ss Laser Delivery Probe	Mnlase, Inc.	GEX	Class II	1994-11-03
K944627	Model 220-Sc Curved Endophotocoagulator Laser	Mnlase, Inc.	GEX	Class II	1994-11-03
K944626	Model 210-as Aspirating Endophotocoagulator Laser	Mnlase, Inc.	GEX	Class II	1994-11-03
K944625	Model 210-Ac Aspirating Endophotocoagulator Laser	Mnlase, Inc.	GEX	Class II	1994-11-03
K944557	Dw250 #91	Rms Div.	EJT	Class II	1994-11-03
K944480	Sealapex	Sybron Dental Specialties, Inc.	EMA	Class II	1994-11-03
K944471	Straight Endophotocoagulator Laser Probe	Mnlase, Inc.	GEX	Class II	1994-11-03
K944470	Curved Endophotocoagulator Laser Probe	Mnlase, Inc.	GEX	Class II	1994-11-03
K943776	Coagulator Cutter, Endoscopic Bipolar and Accessories	Richard Wolf Medical Instruments Corp.	HIN	Class II	1994-11-03
K943664	Intermate Xlv Elastomeric Infusion System	Baxter Healthcare Corporation	MEB	Class II	1994-11-03
K943486	Orafix Special Denture Adhesive	Smithkline Beecham Corp.	KOO	Class I	1994-11-03
K942808	Type I Glass Ionomer Cement	Mion International Corp.	EMA	Class II	1994-11-03
K942548	Jennings Javelin	Jfi Endineering, Inc.	FMK	Class II	1994-11-03
K941559	Paraderm -585M Dermatological Laser	Paradigm Lasers, Inc.	GEX	Class II	1994-11-03
K940790	Babcock/bowel Clamp Forceps	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-11-03
K945204	Urine Collector & Accessories	Nelmed Corp.	FAQ	Class I	1994-11-02
K944870	Jarit Endoscopes, Models 600-600; 600-630; 600-650; and 600-680	J. Jamner Surgical Instruments, Inc.	GCJ	Class II	1994-11-02
K944823	Karl Storz Insulated Dissecting Cannulae, Cannulae, Suction Tubes, Insert Tubes	Karl Storz Endoskop GmbH	GEI	Class II	1994-11-02
K944796	Karl Storz Monopolar Coagulating, Nedle Electrodes	Karl Storz Endoscopy-America, Inc.	GEI	Class II	1994-11-02
K944572	V-Delta N (V-Delta Loy), Aurofluid 2Pf	Metalor	EJT	Class II	1994-11-02
K944562	Multi Level Thc Assay, Synchron Cx Reagent Application	Microgenics Corporation	LDJ	Class II	1994-11-02
K944545	Body Fluids Barrier Kit	Ani Safety, Inc.	FXX	Class II	1994-11-02
K944516	Fluids Pack	Alko Diagnostic Corp.	JIT	Class II	1994-11-02
K944512	Truzone Pfm Disposable Mouthpiece	Monaghan Medical Corp.	BYP	Class I	1994-11-02
K943820	Stat Pak	Magnum Instruments, Inc.	EKJ	Class I	1994-11-02
K943811	Enzyme-Linked Fluorescent Immunoassay	Biomerieux Vitek, Inc.	CFT	Class I	1994-11-02
K943481	Informer Plus	Micro-Tech Medical, Inc.	KMI	Class I	1994-11-02
K943422	Tri-Level Whole Blood Lead Toxicology Control	Utak Lab, Inc.	DIF	Class I	1994-11-02
K943400	Sas Salmonella H D Antiserum	SA Scientific, Ltd	GRM	Class II	1994-11-02
K942891	Summit Total Hip System	Kirschner Medical Corp.	MEH	Class II	1994-11-02
K942827	Sentry Insertion Tray	Sentry Medical Products, Inc.	FOS	Class II	1994-11-02
K942821	Mahe Instruments	Mahe-Medizintechnik	GEI	Class II	1994-11-02
K942753	One Step Specimen Collector/transport Container	Researched, Novel Medical Devices (Rn/Md)	EYZ	Class I	1994-11-02
K942676	Synchron Cx3 Delta	Beckman-Diagnostic Systems Group	JJF	Class I	1994-11-02
K942301	Microvasive Injection Gold Probe	Boston Scientific Corporation	KNS	Class II	1994-11-02
K941041	Solor Care Technologies Corporation Opiates	Solar Technologies Corp.	DJG	Class II	1994-11-02
K940720	Busse Isolation and Procedural Masks	Busse Hospital Disposables	FXX	Class II	1994-11-02
K934111	Mr7000 with Time Manager Software (Tms)	Dynatech Laboratories, Inc.	JQP	Class I	1994-11-02
K945177	4-O2 Jr. (CPR Mouth Barrier)	Eagle Health Supplies	CBP	Class II	1994-11-01
K945143	Dental Laser Fiber System	Incisive Technologies Pty Ltd	GEX	Class II	1994-11-01
K944898	Surgi-Link Bipolar Electrodes	Unimed Surgical Products, Inc.	GEI	Class II	1994-11-01
K944776	Clear Blue Endoscopic Lens Fog Rduction Solution & Cleaning Kit	Blue Planet Industries, Inc.	FEB	Class II	1994-11-01
K944688	Luminous 150 Dual Lampfiberoptic Illuminator	Progressive Dynamics, Inc.	FFS	Class II	1994-11-01
K944632	Model 120-Ss Laser Delivery Probe	Mnlase, Inc.	GEX	Class II	1994-11-01
K944631	Model 120-Sc Laser Delivery Probe	Mnlase, Inc.	GEX	Class II	1994-11-01
K944624	Model 130-Sac Aspirating Endophotocoagulator Laser	Mnlase, Inc.	GEX	Class II	1994-11-01
K944623	Model 130-Sas Aspirating Endophotocoagulator Laser	Mnlase, Inc.	GEX	Class II	1994-11-01
K944622	Model 110-as Aspirating Endophotocoagulator Laser	Mnlase, Inc.	GEX	Class II	1994-11-01