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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2575 of 3530

510(k) clearances, page 2575 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896264	Millar Mikro-Tip Doppler Catheter	Millar LLC.	JOP	Class II	1990-01-24
K896212	Urethral Catheterization Trays	Westmark, Sterile Packing Systems, Inc. (Sps)	FCM	Class II	1990-01-24
K896127	Thora-Klex Chest Drainage Unit	Davol, Inc.	KDQ	Class II	1990-01-24
K896086	Proguard Ii(tm)	Safety-Ject, Inc.	FMF	Class II	1990-01-24
K895823	Surgeon's Gloves	Guey Her Ent. Co., Ltd.	KGO	Class I	1990-01-24
K895387	Puritan-Bennett Companion Emt Liquid Oxygen	Medtronic, Inc.	BYJ	Class II	1990-01-24
K895080	Surgical Gloves	Jet Far Industries, Inc.	FGO	Class II	1990-01-24
K894555	Pari Inhalierboy Type 37.80 Double Insulated	Dura Pharmaceuticals, Inc.	CCQ	Class I	1990-01-24
K893027	Patient Exam Gloves (Mfg Jet Far Indu. Inc.)	Wen Hao, Inc.	LYY	Class I	1990-01-24
K892300	Patient Examination Gloves (Latex)	Ryoden Intl., Ltd.	LYY	Class I	1990-01-24
K900212	Suretex Latex Examination Gloves	Gulf Medical Technologies, Inc.	LYY	Class I	1990-01-23
K897139	Latex Patient Examination Gloves	Kanam Latex Industries Pvt. Ltd.	LYY	Class I	1990-01-23
K896988	Niic Laser System	Niic U.S.A., Inc.	GEX	Class II	1990-01-23
K896789	Model 6000; Volume Neck Coil	Medical Advances, Inc.	LNH	Class II	1990-01-23
K896677	Pc/qct Quantitative Software	The Institute for Radiological Image Sciences, Inc.	KGI	Class II	1990-01-23
K896514	Qs90 Smooth E Arterial Blood Sampler	Radiometer America, Inc	GIM	Class II	1990-01-23
K896486	R-150-Et Collimator	Advantech Corporation	IZX	Class II	1990-01-23
K896384	Fiberoptic Light Source, Foi-1A	JEDMED Instrument Company	EQH	Class I	1990-01-23
K895640	Magnum Plus Latex Condom W/spermicidal Lubricant	Armkel, LLC	HIS	Class II	1990-01-23
K895310	Audiometer/master Hearing Aid, Maico Model Mf7	Maico Hearing Instruments, Inc.	EWO	Class II	1990-01-23
K894888	Shimadzu Whole Body X-Ray CT Scanner Sct-3000Te	Shimadzu Medical Systems	JAK	Class II	1990-01-23
K894260	Ae-105D Diagnostic Tympanometer	American Electromedics Corp.	ETY	Class II	1990-01-23
K893887	Bestone Model Ite & Canal	Bestone Hearing Instruments	ESD	Class I	1990-01-23
K893025	Exam Gloves (Mfg. Guey Her ENT. Co. Ltd)	Wen Hao, Inc.	LYY	Class I	1990-01-23
K892307	Patient Examination Gloves (Latex)	Guangming Latex Factory	LYY	Class I	1990-01-23
K891490	Seamless Latex Patient Examination Gloves	Med-Care Sdn. Bhd.	LYY	Class I	1990-01-23
K900167	Turbiquant Immunoglobulin & Albumin Kit	Behring Diagnostics, Inc.	DCF	Class II	1990-01-22
K900028	Allercoat Microplate System	Kallestad Diag, A Div. of Erbamont, Inc.	JJQ	Class I	1990-01-22
K897083	Ventresign Strep a Test	Ventrex Laboratories, Inc.	GTZ	Class I	1990-01-22
K897066	Patient Examination Gloves	Golden Gloves Intl.	LYY	Class I	1990-01-22
K896963	Trimode Sp Dental Intra Oral X-Ray	Tempo Technology, Inc.	EAP	Class II	1990-01-22
K896936	L.a.s.p. Lumbar and Sacral Pad, Reposition. Snap	Labeltape Meditect, Inc.	GXY	Class II	1990-01-22
K896832	Filt-R-All Bacterial Filter	Inhalation Plastics, Inc.	CAH	Class II	1990-01-22
K896721	Model 7-at Treatment Chamber	J. H. Emerson Co.	LGM	Class II	1990-01-22
K896683	Compact Video Imager Mp4000 Series III	International Imaging Electronics	LMC	Class II	1990-01-22
K896665	Ext-600 Table, Radiographic, Elevating	Rms Div.	IZZ	Class II	1990-01-22
K896637	Access(tm), Software Release 4.11P	Diasonics, Inc.	LPH	Class II	1990-01-22
K896560	Mucous Trap	Westmark, Sterile Packing Systems, Inc. (Sps)	BSY	Class I	1990-01-22
K896548	Modified Aire-Cuf Silicone Tracheostomy Tube	Bivona Medical Technologies	JOH	Class II	1990-01-22
K896547	Modified Fome-Cuf Silicone Tracheostomy Tube	Bivona Medical Technologies	JOH	Class II	1990-01-22
K896510	Tech Med Nitrous Oxide Sedation Nasal Inhaler Cir.	Technical Medical Products, Inc.	CBN	Class II	1990-01-22
K896502	Porges Biopsy & Foreign Body Forceps	Porges Corp.	OCZ	Class II	1990-01-22
K896476	Disp. Radioaerosol Kit (Mp-400-M) to Fit Shield	Medipart Jerry Alexander	IYT	Class II	1990-01-22
K896475	Disp. Radioaerosol Kit (Mp-400) to Fit Lead Shield	Medipart Jerry Alexander	IYT	Class II	1990-01-22
K896426	Porges Sphincterotomes	Porges Corp.	KNS	Class II	1990-01-22
K896423	Porges Biliary Stents	Porges Corp.	FGE	Class II	1990-01-22
K896385	Ureteral Access Set	Applied Urology, Inc.	KOD	Class II	1990-01-22
K896376	Porges Nasobiliary Drain	Porges Corp.	FGE	Class II	1990-01-22
K896365	Babyflex Heated Infant Breathing Circuit	Baxter Healthcare Corporation	CAI	Class I	1990-01-22
K896315	Bear Vh820 Disposable Chamber Assembly	Bear Medical Systems, Inc.	BTT	Class II	1990-01-22