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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3073 of 3528

510(k) clearances, page 3073 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841779	Electronic Muscle Exercise Equipment	Bloomex International, Inc.	IPF	Class II	1984-05-30
K841571	Maxi-Miser Water Transfer Set 1021/1022	Nova-Ventrx			1984-05-30
K841569	Maxi-Miser Humidifier Insert 1020	Nova-Ventrx			1984-05-30
K841404	Prima 236-02 Nonprogrammable Cardiac	Intermedics, Inc.	DXY	Class III	1984-05-30
K841194	Medical Chair, Multipurpose Tast Support	Neutral Pos-Chair Co.	INM	Class I	1984-05-30
K841090	Ventilator External Body Negative Press	Porta-Lung Co.	BYT	Class II	1984-05-30
K841006	Ear Knife-Various	Premier Dental Products Co	JYO	Class I	1984-05-30
K841005	Tonsil Knife-Various	Premier Dental Products Co	KBQ	Class I	1984-05-30
K840833	Preg Beta Blus Slide	Intl. Diagnostic, Inc.	JHJ	Class II	1984-05-30
K840757	Elvi 444 Bilitron	Logos Scientific, Inc.	CIG	Class II	1984-05-30
K840620	Tpn/cvp Dressing Change Kit	Marwood Medical, Inc.	FMC	Class I	1984-05-30
K840532	Hemoperfusion System Tp-400	Extracorporeal Medical Specialities, Inc.	FLD	Class II	1984-05-30
K840498	Exu-Dry Burn-Trauma Dressing-Various	Fraass Survival Systems, Inc.			1984-05-30
K840488	Lifecycle Aerobic Monitor 123	Heart Rate, Inc.	BZQ	Class II	1984-05-30
K840262	Hancock Pericardial Patch	Extracorporeal Medical Specialities, Inc.	DXZ	Class II	1984-05-30
K840242	Poly Plug Cement Restrictor	Latham Manufacturer	JDS	Class II	1984-05-30
K840162	Drager Sphygmomed	Draeger, Inc.	DXN	Class II	1984-05-30
K834367	Suture Removal Wound Closure-Instru-	Sterling Multi-Products, Inc.	HTD	Class I	1984-05-30
K834106	Intravenous Infusion Controller	Cutter Laboratories, Inc.	LDR	Class II	1984-05-30
K833903	Benzethonium Chloride	Blairex Laboratories, Inc.	HPX	Unclassified	1984-05-30
K833720	Transthoracic/transabdominal-Tray	Applied Medical Devices, Inc.	GDM	Class I	1984-05-30
K831117	Micromat W/various Models	Pmt, Inc.	FNW	Class II	1984-05-30
K841001	Ear Curette, Various	Premier Dental Products Co	JYG	Class I	1984-05-29
K842008	Marquest Micro Stik 9000 Series	Marquest Medical Products, Inc.	CBT	Class I	1984-05-25
K841925	Dsl Ferritin Irma	Diagnostic Systems Laboratories, Inc.	DBF	Class II	1984-05-25
K841841	Differential Culture Med. Mannitol Salt	Microline Scientific	JSI	Class I	1984-05-25
K841840	Selective Culture Med. Phenylethyl Alco	Microline Scientific	JSJ	Class I	1984-05-25
K841839	Selective Culture Med. Selective Strep	Microline Scientific	JSJ	Class I	1984-05-25
K841632	Code-a-Well Series 200 Plate	Plastic Injectors, Inc.	LIB	Class I	1984-05-25
K841610	Components for Potassium, Sodium Chlo	Shaban Mfg. Co.	JGT	Class II	1984-05-25
K841609	Components for Partial Pressure Elee	Shaban Mfg. Co.	CHL	Class II	1984-05-25
K841583	Sporstrip	Skyland Scientific Services, Inc.	FRC	Class II	1984-05-25
K841021	Hemotec, Hepcon/sys B-10 Heparin/protam	Hemotec, Inc.	JOX	Class II	1984-05-25
K840943	Endo-Ject	Autovage	BTR	Class II	1984-05-25
K840807	Throat Moi-Stir	Kingswood Laboratories, Inc.	LFD	Unclassified	1984-05-25
K840792	Infant Radiant Warmer	Hatch Bio Medical	FMT	Class II	1984-05-25
K840335	Sheer Energy Panty Hose	Leggs Products, Inc.	DWL	Class II	1984-05-25
K834616	Amnio Stat-Flm Agglutination Test	Hana Biologics, Inc.	JHG	Class II	1984-05-25
K834228	Lithotriptor Electrode 4.5F	Monaghan Medical Corp.	FFK	Class II	1984-05-25
K833822	P-S Medical Csf Access Dev 15Mm/25mm	Pudenz-Schulte Medical Research Corp.	LKG	Class II	1984-05-25
K833522	Neuro Sector Fixation Device	Advanced Technology Laboratories, Inc.	GXW	Class II	1984-05-25
K842003	Ohio Waste Gas Scavenging Interface	Ohio Medical Products	CBN	Class II	1984-05-23
K841994	Ezy-Ramp	Ezy-Ramp Co.			1984-05-23
K841954	Oasis Club Hydromassage	Prexcor America, Inc.	ILJ	Class II	1984-05-23
K841921	Alpha Plus 1	Alpha Unlimited, Inc.	ITI	Class II	1984-05-23
K841920	Mac-Multi-Adjustable Chair	Alpha Unlimited, Inc.	IPL	Class II	1984-05-23
K841919	Alpha Tri-Kart	Alpha Unlimited, Inc.	INI	Class II	1984-05-23
K841912	Alpha 4 X 4	Alpha Unlimited, Inc.	ITI	Class II	1984-05-23
K841911	Alpha Push Kart	Alpha Unlimited, Inc.	INM	Class I	1984-05-23
K841778	D.l. Scope Blade & Handle	North American Medical Products, Inc.	CCW	Class I	1984-05-23