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 2151 of 3531

510(k) clearances, page 2151 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944621	Model 110-Ac Aspirating Endophotocoagulator Laser	Mnlase, Inc.	GEX	Class II	1994-11-01
K944472	Curvd Endophotocogulator Laser Probe	Mnlase, Inc.	GEX	Class II	1994-11-01
K944418	The Spacemaker and the Spacemaker II	General Surgical Innovations	GCJ	Class II	1994-11-01
K944282	Laser Delivery Probe	Mnlase, Inc.	GEX	Class II	1994-11-01
K944151	Optical Fiber for ENT Applications	Cardiogenes	GEX	Class II	1994-11-01
K943833	Sterile Water for Irration	Orion Life Systems, Inc.	JOL	Class II	1994-11-01
K943752	Rimeco Midstream Urine Collector	Rimeco Products, Inc.	FOC	Class II	1994-11-01
K943685	Mic Disposable Snare	Medical Innovations, Inc.	KNT	Class II	1994-11-01
K942635	Meadox Surgimed Noprofile Olbert Catheter System	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1994-11-01
K942094	Cordis Savvy Pta Balloon Catheter	Cordis US Corp.	LIT	Class II	1994-11-01
K941750	Proposed Trademan Microvasive Polypectomy Snares	Boston Scientific Corporation	FDI	Class II	1994-11-01
K940836	Peaklog and Display Software	Tamarac Systems Corp.	BZH	Class II	1994-11-01
K940835	Peaklog and Display Software	Medtrac Technologies Corp.	BZH	Class II	1994-11-01
K940467	Remington Medical Disposable Extension Cable Fas-Loc Fl-601	Remington Medical	DTE	Class II	1994-11-01
K935429	Arbo H90, H91, H135 Disposable Monitoring Electrodes	Arbo Medical, Inc.	DRX	Class II	1994-11-01
K935428	Bennett X-Ray Digital Spot Imager	Bennett X-Ray Technologies	IZH	Class II	1994-11-01
K934644	K3 System	Astro-Med, Inc.	DRT	Class II	1994-11-01
K933081	Oxlife Oxygen Concentrator	Oxlife, Inc.	CAW	Class II	1994-11-01
K933057	Multilite Erbium:yag Surgical Laser System	Continuum Electro-Optics, Inc.	GEX	Class II	1994-11-01
K930599	Body Fat Analyzer Model Tbf-105	Tanita Corp. of America	DSB	Class II	1994-11-01
K926378	Thermabond V	Dentecon, Inc.	EJT	Class II	1994-11-01
K944247	Cardiochex Ckmb Immunoinhibition Control	Cala Diagnostics	JJT	Class I	1994-10-31
K944246	Cardiochex Ckmb Mass Measurement Control	Cala Diagnostics	JJT	Class I	1994-10-31
K943780	Negative Control Strips for Urinalysis (Chex-Stix, Clinitek Auto 2000, Clinitex Atlas)	Kulzer GmbH	JJW	Class I	1994-10-31
K943705	Folic Acid	Siemens Healthcare Diagnostics Inc.	CGN	Class II	1994-10-31
K943683	B-D Safe-Clip	Becton Dickinson Consumer Products	FMI	Class II	1994-10-31
K943300	Depuy Porous Coated Global Shoulder	Depuy, Inc.	KWS	Class II	1994-10-31
K942469	Protectaide CPR Protection Pack	Protectaide, Inc.	CBP	Class II	1994-10-31
K942468	Protectaide CPR Protection Pack No. 22100	Protectaide, Inc.	CBP	Class II	1994-10-31
K941834	Auditory Cassette	Ltmlt, Inc.	KLW	Class II	1994-10-31
K941797	Immulite Shbg	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	1994-10-31
K941573	Roche Reagent	Roche Diagnostic Systems, Inc.	CHH	Class I	1994-10-31
K940979	Gen-Probe Pace 2C Syst Chlamydia Trac/neisser Gonorr	Hologic, Inc.	LSL	Class II	1994-10-31
K935599	Hcg/tsh Control- Level 1/Level 2/Level 3	Clinical Controls, Inc.	JJY	Class I	1994-10-31
K933264	Ritch Nylon Suture Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1994-10-31
K933086	Afsc Hemo Control #5331, Aa2 Hemo Control #5328	Helena Laboratories, Corp.	JCM	Class II	1994-10-31
K924486	Card Guard, Model Cg-9000	Card Guard Scientific Survival, Ltd.	DXH	Class II	1994-10-31
K945134	Portable Patient Monitor	Hewlett-Packard Co.	MHX	Class II	1994-10-28
K944784	Mini-Op Laparoscopic Lasso	Uresil, LLC	GEI	Class II	1994-10-28
K944189	Transparent Anesthesia Filter	Anetec, Inc.	CAH	Class II	1994-10-28
K944142	P2 Exam Gloves	Biosafety Systems, Inc.	LYY	Class I	1994-10-28
K944095	P2 Nitrile Exam Gloves	Biosafety Systems, Inc.	LYY	Class I	1994-10-28
K943874	Precison Thermoplastic Components Gas Ampling Lines and Connectors	Precision Thermoplastic Components, Inc.	CAH	Class II	1994-10-28
K941883	Contact Lens	Airperm, Inc.	HQD	Class II	1994-10-28
K940152	Camera Cover with Tear Tip	Hydro-Med Products, Inc.	FEM	Class I	1994-10-28
K934630	Universal Video/laser Arm Drape	Hydro-Med Products, Inc.	KKX	Class II	1994-10-28
K931988	3P (Pulmonary Percussive Pack)	Delta Medical Manuf, Inc.	BYI	Class II	1994-10-28
K930509	Pm Pump Compressor	Precision Medical, Inc.	BTI	Class II	1994-10-28
K921982	Matrx Hope(r) 5 Resuscitator	Matrix Medica, Inc.	BTM	Class II	1994-10-28
K945034	Conmed ECG Patient Safety Cables and Leadwires-Removal and Permanently-Attached Leadwires	Conmedcorp	DSA	Class II	1994-10-27