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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3044 of 3529

510(k) clearances, page 3044 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K842859	Microscope Mitts Support Tray Cover	Chiron Vision Corp.	HJO	Class II	1984-10-05
K842838	Safe & Soft Panty Shields	Ipco Corp.	HHD	Class I	1984-10-05
K842376	Ultramark 4 Ultrasound Sys	Advanced Technology Laboratories, Inc.	IYO	Class II	1984-10-05
K842047	Ortho* Rsv Antigen Elisa Test Sys	Ortho Diagnostic Systems, Inc.	LKT	Class I	1984-10-05
K841861	Canon Autoref R-10	Canon Medical Components U.S.A., Inc.	HKO	Class I	1984-10-05
K841738	Amer. Surgical Corp. Extra Plus Pak	American Surgical Company, LLC	HQE	Class II	1984-10-05
K840834	Corneal Light Shield	Gabl, Inc.	HOY	Class I	1984-10-05
K840181	Catarex/ultrasonics Kit	Calliope Corp.	HQC	Class II	1984-10-05
K840063	Catarex Vitrecutter I/a Dispos. Cut	Calliope Corp.	HQC	Class II	1984-10-05
K843811	Bunn 3001 Oxygen Concentrator	The John Bunn Co.	CAW	Class II	1984-10-04
K843800	Ohmeda Rm121 Respirometer	GE Healthcare	BZK	Class II	1984-10-04
K843799	Ohmeda Rm311 Respirometer	GE Healthcare	BZK	Class II	1984-10-04
K843737	Pneupac Instant Action Ventilator/resus	Pneupac, Ltd.	CBK	Class II	1984-10-04
K843720	Cotton Tipped Applicators, Single	Abco Dealers, Inc.	KXF	Class I	1984-10-04
K843599	Ohmeda Model 5200 CO2 Monitor	GE Healthcare	CCK	Class II	1984-10-04
K843524	Linder Nasopharyngeal Airway	Polamedco, Inc.	BTQ	Class I	1984-10-04
K843520	Warexin Recommended Alternative Dialyz	Mesa Medical, Inc.	LIF	Class II	1984-10-04
K843501	Balloon Dilation Catheter	Advanced Cardiovascular Systems, Inc.	LIT	Class II	1984-10-04
K843490	Tube-Stat	Concept, Inc.	BSR	Class I	1984-10-04
K843407	Encore Hcg Reagent	Hybritech, Inc.	JHI	Class II	1984-10-04
K843302	New Allerg. Coated Microfilter Well Stri	Diagnostic Reagent Tech.	DHB	Class II	1984-10-04
K843198	Video Urodynamics Sys 1906B-Y & 1906C-Y	Life-Tech Intl., Inc.	FET	Class II	1984-10-04
K843158	Sexton Cystotomy Urine Pump	Holter-Hausner Intl.	KOB	Class II	1984-10-04
K843126	Mediflex Drainage Bag	Mediflex Intl.	KNX	Class II	1984-10-04
K842840	Curity Silicone Nephrostomy Catheter	The Kendal Co.	LJE	Unclassified	1984-10-04
K842795	Maxi-Miser Humidifier Insert 1030	Nova-Ventrx	BTT	Class II	1984-10-04
K842794	Maxi-Miser Humidifier Insert 1020 & 1021	Nova-Ventrx	BTT	Class II	1984-10-04
K842640	Spacelabs Icr Arrhythmia Master I Holter	Spacelabs, Inc.	DSI	Class II	1984-10-04
K842610	Guidelines for Pediatric Anesthesia	Critical Care Micro Computing	CAC	Class II	1984-10-04
K842497	Servomed Oxymonito Smk 363	Litton Datamedix	KLK	Class II	1984-10-04
K841184	Electro-Nerve Stimulator Hl	BioMedical Life Systems Inc.	GZJ	Class II	1984-10-04
K843545	Tsh Quik Ria Kit	Pacific Biotech, Inc.	JLW	Class II	1984-10-02
K843521	Differentiation Disks Nitrate	Difco Laboratories, Inc.	JTO	Class I	1984-10-02
K843492	Neomycin Blood Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSI	Class I	1984-10-02
K843427	Gill Papanicolaou Stain Ea-1 & 2 Og-6	Accra Laboratories, Inc.	HZJ	Class I	1984-10-02
K843425	Harris Hematoxylin, Mercury Free, Acid	Accra Laboratories, Inc.	HYK	Class I	1984-10-02
K843374	Nd-Yag Laser for Palliation of Gi Malign	Endo Lase, Inc.	LNK	Class II	1984-10-02
K843293	Nd-Yag Laser for Urological Surgery	Endo Lase, Inc.	LNK	Class II	1984-10-02
K843240	Laser for Genitourinary Applic. 4000	Cooper Lasersonics, Inc.	LNK	Class II	1984-10-02
K842679	Esophageal Dilator Set	Mill-Rose Laboratory	FAT	Class II	1984-10-02
K842639	Amer. Edwards Lab Diaflex Ureteral Dila	American Edwards Laboratories	EZN	Class II	1984-10-02
K842632	Dilator/sheath Set	American Edwards Laboratories	EZN	Class II	1984-10-02
K842599	Meter Mouse System	Mem, Inc.			1984-10-02
K842360	Dorr Hip Prosthesis Femoral Component	Carbomedics, Inc.	JDI	Class II	1984-10-02
K842225	Hemodial Concentrate Mixing Apparatus	Lmf Medical Research & Manufacturing, Inc.	FKQ	Class II	1984-10-02
K842206	Diaflex Nephrostomy Balloon Dilator	American Edwards Laboratories	EZN	Class II	1984-10-02
K842147	Cath-Tech Cholangiography Catheter	Catheter Technology Corp.	FGE	Class II	1984-10-02
K841709	48 Hour Biological Indicators Sporstrip	Skyland Scientific Services, Inc.	FRC	Class II	1984-10-02
K841363	Heart Rate/respiration Simulator 8310	Aequitron Medical, Inc.	DRT	Class II	1984-10-02
K841256	Models 78551A 78552A	Hewlett-Packard Co.	DXG	Class II	1984-10-02