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 2226 of 3531

510(k) clearances, page 2226 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934573	Hmp Titanium Low Profile Port	Boston Scientific Corporation	LJT	Class II	1994-02-25
K934557	Control Cable System	Depuy, Inc.	JDQ	Class II	1994-02-25
K934527	Fascia Stitcher	Laparomed Corp.	GCJ	Class II	1994-02-25
K934504	Hmp Dual Titanium Port	Boston Scientific Corporation	LJT	Class II	1994-02-25
K934388	Qms Phenobarbital	Seradyn, Inc.	LFN	Class II	1994-02-25
K934281	Phx Technologies Corp.,hook Electrode, 5Mm	Phx Technologies Corp.	GEI	Class II	1994-02-25
K933990	Hmp Titanium Port	Boston Scientific Corporation	LJT	Class II	1994-02-25
K933986	Hmp Polysulfone Port	Boston Scientific Corporation	LJT	Class II	1994-02-25
K933962	Gm Continuous Flow Biopsy Probe	Gm Engineering, Inc.	FDC	Class II	1994-02-25
K933908	Medrad CT Custom Convenience Kit	Medrad, Inc.	DXT	Class II	1994-02-25
K933880	Sl Series Surgical Laser Systems	Laserscope	GEX	Class II	1994-02-25
K933506	Syringe Infuser	Baxa Corp.	FRN	Class II	1994-02-25
K933415	Detect (Tm) Cytology Brush	Cook Ob/Gyn	HHT	Class II	1994-02-25
K933126	Comfortcare System	Patsy J. Trisler, J.D.	EYZ	Class I	1994-02-25
K933088	Plato 3000	Rosys, Inc.	JQW	Class I	1994-02-25
K932832	Primus Insulated Forceps	Marlo Surgical Technology	HET	Class II	1994-02-25
K932818	Hm-880	Hill-Med, Inc.	GEI	Class II	1994-02-25
K932634	Nu-Tip(tm) Forceps:graspers/dissectors/sutures	Marlo Surgical Technology	HET	Class II	1994-02-25
K931748	Centlurion Disp Steri Dental/hygiene Pack/trays	Centurion Medical Products, LP	LJT	Class II	1994-02-25
K930930	Coast Medical, Inc. Rectal Probe	Coast Medical Corp.	FLL	Class II	1994-02-25
K930575	Kamppeter Anomaloscope	Bova Intl.	HIW	Class I	1994-02-25
K930404	Dib Infusor	Novacon Corp.	MEB	Class II	1994-02-25
K930206	Ps Medical Ipi Access Kit	Pudenz-Schulte Medical Research Corp.	LJT	Class II	1994-02-25
K930030	Suction Tubes: House, Baron	Thomasville Medical Assoc.	JCX	Class II	1994-02-25
K926540	Sopher and Bierer Ovum Forceps	Thomasville Medical Assoc.	HLZ	Class II	1994-02-25
K926536	Disposable Plastic Vaginal Specula	Thomasville Medical Assoc.	HIB	Class II	1994-02-25
K926535	Gomco Circumcision Clamp	Thomasville Medical Assoc.	HFX	Class II	1994-02-25
K926533	Z-Clamp Forceps	Thomasville Medical Assoc.	HCZ	Class II	1994-02-25
K926532	Endo Cervical Curette	Thomasville Medical Assoc.	KNA	Class II	1994-02-25
K926531	Hysterectomy Forceps	Thomasville Medical Assoc.	HCZ	Class II	1994-02-25
K926527	Roto Fit Biopsy Forceps	Thomasville Medical Assoc.	HFB	Class I	1994-02-25
K926484	Corson Myoma Grasping Forceps	Thomasville Medical Assoc.	HCZ	Class II	1994-02-25
K926471	Mogan Circumcision Clamp	Thomasville Medical Assoc.	HFX	Class II	1994-02-25
K926080	Dmi Laparoscopic Irrigation Pump	Diversified Medical Instruments, Inc.	GCJ	Class II	1994-02-25
K925791	Exac-Temp & Clini-Temp Probe W/temperature Sensor	DeRoyal Industries, Inc.	FLL	Class II	1994-02-25
K925630	Elastoplast Heat Plaster	Beiersdorf, Inc.	IRT	Class II	1994-02-25
K923937	Hydro Floss	Hydro Floss, Inc.	EFS	Class I	1994-02-25
K923917	Elipase Human Pancreatic Lipase Enzymeimmunoassay	Nuclear Diagnostics, Inc.	CHI	Class I	1994-02-25
K922673	Flexible Ceramic Ropes and Tapes for Bonding	Glasspan, Inc.	ELS	Class II	1994-02-25
K911727	Infraderm; Touch 'N Tone Plus	Conair LLC.	ISA	Class I	1994-02-25
K940208	Aesculap Accu-Dermatome	Aesculap Inc	GFD	Class I	1994-02-24
K936081	I-Stat Tests for Acid-Base Parameters	I-Stat Corp.	CHL	Class II	1994-02-24
K935869	Dextren(tm) Powder Free Hypoallergenic Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	KGO	Class I	1994-02-24
K935863	Sas(tm) Direct Monoclonal Hcg	SA Scientific, Ltd	JHJ	Class II	1994-02-24
K935840	Tl 20W/12/rs & Tl 40W/12/rs	Philips Lighting Co.	FTC	Class II	1994-02-24
K935665	Intrauterine Sound	Rocket of London, Ltd.	HHM	Class I	1994-02-24
K935391	Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk Pack	3M Health Care, Sarns	GFA	Class I	1994-02-24
K935236	Flow Controlling Extension Set	Block Medical, Inc.	LDR	Class II	1994-02-24
K934662	Unscented Menstrual Pad	Eldari, Ltd.	HHD	Class I	1994-02-24
K934516	Advance Pregnancy Test Modification	Ortho Pharmaceutical Corp.	LCX	Class II	1994-02-24