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 2236 of 3531

510(k) clearances, page 2236 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932010	V.a.d. Access Kit	Clinipad Corp.	LJT	Class II	1994-02-03
K931522	Fascial Closure Device	Origin Medsystems, Inc.	GCJ	Class II	1994-02-03
K931266	Battery Pack #1012Nc	Portable Power Systems, Inc.	LDD	Class II	1994-02-03
K931241	Fast'n'flammatory Kit	Techlab, Inc.	GIA	Class I	1994-02-03
K931091	Disposable Ama Sterile Drape Sheet, Cat. No. 5252	Alliance Medical Corp.	KKX	Class II	1994-02-03
K930795	Medigloves, Fisherbrand, Mediproducts Gloves	Medigloves, Ltd.	LYY	Class I	1994-02-03
K930794	Medigloves, Medpac, Boston, Fisherbrand, Gloves	Medigloves, Ltd.	KGO	Class I	1994-02-03
K930180	Biopsy Cup Forceps	Surgical Technologies, Inc.	GCJ	Class II	1994-02-03
K926405	.9% Normal Saline Tube/sterile Water Tube	Gam-Med Packaging Corp.	FOZ	Class II	1994-02-03
K926121	Brass Nick Impres Tray/amalgam Car/syrin Cart/arti	Dentmed, Ltd.	EJI	Class II	1994-02-03
K925850	Disposable Universal Laporascopic Scissors	H.S. Intl. Co., Inc.	GEI	Class II	1994-02-03
K925185	Isolair 2 Fluid Resist Surg/proce/cone/earloop Mas	Louis M. Gerson Co., Inc.	FXX	Class II	1994-02-03
K924357	Latex Patient Examination Gloves	Asia Pacific Latex Sdn Bhd	LYY	Class I	1994-02-03
K924356	Latex Patient Examination Gloves	Medi Pure Corp.	LYY	Class I	1994-02-03
K921335	Ultraflow Suction-Irrigation Cannula	Endoscopic Surgical Products, Inc.	HET	Class II	1994-02-03
K914541	Sperm Maintenance Medium with Glycerol	Irvine Scientific LLC	MFD	Class II	1994-02-03
K914137	Ha-Biontegrated Dental Implant Systems	Lifecore Biomedical LLC	DZE	Class II	1994-02-03
K911120	Decontaminating Machines, Ls-850, Ls-76, Dw/t-216, T-21	Hamo USA, Inc.	MEC	Class II	1994-02-03
K936244	Regency Bracket	Mid-American Dental Specialties, Inc.	EJF	Class I	1994-02-02
K936243	Regency Tube	Ortho Specialties	DZD	Class I	1994-02-02
K936095	Gauze Sponge	Dukal Corp.	EFQ	Unclassified	1994-02-02
K935993	Surgical Sponge X-Ray Detectable	McNeil Healthcare LLC	GDY	Class I	1994-02-02
K935796	Hydroderm Breathable Transparent Dressing	Wilshire Medical Products	MGP	Unclassified	1994-02-02
K935271	Therapeutic Ultrasound and Stimulator	Chattanooga Group, Inc.	IMG	Class II	1994-02-02
K935211	Walk N Chair	Brookefield Hunter, Inc.	IOR	Class I	1994-02-02
K935033	Multi-Comfort Powder Free	Perusahaan Intan Emas Sdn. Bhd.	LYY	Class I	1994-02-02
K934689	Low Air Loss Mattress, Modification	Cardio Systems, Inc.	INX	Class II	1994-02-02
K934673	Kacey Disposable Infant Heel Warmer	K & C Medical, Inc.	IMD	Class I	1994-02-02
K934408	Partners Latex Exam Gloves Plus Multiple Names	Sjs Supreme, Inc.	LYY	Class I	1994-02-02
K933974	Windmere Massage Mate	Windmere Corp.	IRO	Class I	1994-02-02
K933443	Combi 2.5 Intersegmental Traction Table	Williams Healthcare Systems, LLC.	JFB	Class II	1994-02-02
K932796	Owens Trocar	Owens Industries, Inc.	GCJ	Class II	1994-02-02
K931843	Hot/ice System Sterile Conformable/disp. Blankets	Hollister, Inc.	ILO	Class II	1994-02-02
K930692	Latham Table	I-Rep, Inc.	INQ	Class I	1994-02-02
K930242	Introde Int-8	Neuromed, Inc.	GZB	Class II	1994-02-02
K926495	Sil-Slip Round Wound Drain (Coated)/blue Stripe	Sil-Med Corp.	GBX	Class I	1994-02-02
K926408	Sil-Slip Flat Suction Drain	Sil-Med Corp.	GBX	Class I	1994-02-02
K925820	Arthritic Heat Wrap	Conair LLC.	IRT	Class II	1994-02-02
K923238	Sonassage	Conair LLC.	IRO	Class I	1994-02-02
K915490	Medcomp Peritoneal Dialysis Catheters	Medical Components, Inc.	FJS	Class II	1994-02-02
K935779	Agafar Face Shield	Infection Control Products, Inc.	LYU	Class I	1994-02-01
K934881	Reflections	Cdb Corp.	EJF	Class I	1994-02-01
K934815	Air Compressor, Model Pac 6.7	Defiance Electronics, Inc.	EIA	Class I	1994-02-01
K934658	Gsi 60 Dpoae System	Lucas Grason-Stadler, Inc.	EWO	Class II	1994-02-01
K934382	Vci Suction/irrigation Tubing Set	Vital Concepts, Inc.	JOL	Class II	1994-02-01
K934171	Ultra Shield Pf	Medical Resources International, Inc.	LYY	Class I	1994-02-01
K933772	Punch Surgical	Mahe-Medizintechnik	LXH	Class I	1994-02-01
K933623	Eureka	J.F. Jelenko & Co., Inc.	EJT	Class II	1994-02-01
K933263	Comfit	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-02-01
K933011	Microvasive Urological Balloon Dilation Catheter	Boston Scientific Corporation	EZN	Class II	1994-02-01