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 2342 of 3531

510(k) clearances, page 2342 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924526	Denture Plastic Teeth	Austenal, Inc.	ELM	Class II	1992-11-04
K924422	Palabond	Kulzer GmbH	EBI	Class II	1992-11-04
K923972	Ophthalmic Fluid Distribution Sets	Visitec Co.	FPK	Class II	1992-11-04
K923909	Cement Restrictor for Proforma and Perfecta Total	Orthomet, Inc.	LZN	Class II	1992-11-04
K923898	C-Fit Cemented Hip Stem	Turnkey Intergration USA, Inc.	JDI	Class II	1992-11-04
K923644	Dw243-64	Ivoclar USA, Inc.	EJS	Class II	1992-11-04
K922988	Eco/dental General Dental Pack	Dyna-Pace Systems, Inc.	EKJ	Class I	1992-11-04
K922291	Personal 120/210 Laptop Stress Option	Biosound, Inc.	DPS	Class II	1992-11-04
K922075	Avoximeter	A-Vox Systems, Inc.	DQA	Class II	1992-11-04
K922007	Ysi Model 441A Airway Temperature Probe	Yellow Springs Instrument Co., Inc.	BZT	Class II	1992-11-04
K921895	Tissue Patch, Tissue Graft	Bio-Vascular, Inc.	DXZ	Class II	1992-11-04
K921173	Type 1 Dental Cement	Centrix, Inc.	EMA	Class II	1992-11-04
K920905	Bioforce Wire	Gac Intl., Inc.	DZC	Class I	1992-11-04
K915865	Ait Implant System	American Implant Technology, Inc.	DZE	Class II	1992-11-04
K915641	Zirconia Ceramic Modular Head 9Type II Taper	Zimmer GmbH	LZO	Class II	1992-11-04
K915491	Curelle	Bioteque Corp.	HHK	Class II	1992-11-04
K924912	Phonak Pico-Forte C-2 Bte Hearing Instrument	Phonak, Inc.	ESD	Class I	1992-11-03
K924185	Dfs Genius Bte	GN Danavox, Inc.	ESD	Class I	1992-11-03
K923327	Stethoscope Cover	Anup Chakraborty Co.	LDE	Class I	1992-11-03
K922837	S1500 Xenon Light Source	Endomedix	HBI	Class II	1992-11-03
K922548	Medelec 2110 and 2114 EEG	Medelec Intl. Corp.	GWQ	Class II	1992-11-03
K921764	Dalla Bona Ball & Sockey Attach. Snap Type Precis	Implant Support Systems, Inc.	DZE	Class II	1992-11-03
K921627	Digital Blood Pressure Monitor Model #Uf-101	Showa Engineering Co., Ltd.	DXN	Class II	1992-11-03
K921493	Ls100 Halogen Examination Light, Model No: 44100	Welch Allyn Inc	KZF	Class I	1992-11-03
K920290	Kinamed 32Mm Bioceram-Z Toatal Hip Femoral Ball	Kinamed Inc	LZO	Class II	1992-11-03
K914970	Cardiovit Cs-100	Schiller America, Inc.	LOS		1992-11-03
K913995	Vitalert 3000 Monitoring System	Draeger, Inc.	CCK	Class II	1992-11-03
K924797	Cefpodoxime 10 Mcg, Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1992-11-02
K924462	Stc Diagnostics Auto-Lyte(tm) Pcp Eia	Solarcare Technologies Corp,Inc.	LCM	Unclassified	1992-11-02
K924248	Accutex Sle Latex Test	J.S. Medical Assoc.	LJM	Class II	1992-11-02
K924087	Kalestad Ana Microplate Eia	Bio-Rad Laboratories Inc.	LJM	Class II	1992-11-02
K924047	Sub-4 Small Vessel Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	1992-11-02
K924037	Accutex Im Rbc Test	J.S. Medical Assoc.	KTN	Class II	1992-11-02
K923873	Syva Emit II Propoxyphene Assay	Syva Co.	JXN	Class II	1992-11-02
K923658	Rep Immunofix	Helena Laboratories, Corp.	CFF	Class II	1992-11-02
K923566	Nizyme Test Kit	Remel Inc	JSX	Class I	1992-11-02
K923129	King Diagnostics Glucose (Hk) Reagent	King Diagnostics, Inc.	CFR	Class II	1992-11-02
K922572	321Q Minimum Energy Tinnitus Suppressor	Microbio-Medics, Inc.	KLW	Class II	1992-11-02
K921906	Harris Model 2000	Harris Mfg. Co.	LMC	Class II	1992-11-02
K921898	Tad Model #9655	Loric Technology	DRS	Class II	1992-11-02
K921821	Ibt Model Svi	Biomagnetic Technologies, Inc.	CBK	Class II	1992-11-02
K921477	I-Stat(tm) Levels 1,2,3 Controls	I-Stat Corp.	JJY	Class I	1992-11-02
K921381	Medgraphix Intl Vr 1000 Series	Medgraphix Intl.	LMC	Class II	1992-11-02
K921108	Cms Record and Verify	Elekta Limited	KPQ	Class II	1992-11-02
K920906	Dgh-500 Pachymeter	DGH Technology, Inc.	IYO	Class II	1992-11-02
K914607	Sehrist Volume Ventilator, Model 2200B	Sechrist Industries Inc	CBK	Class II	1992-11-02
K924406	Conveen(r) Leg Bag(500 Ml)	MEDLINE INDUSTRIES, LP - Northfield	FAQ	Class I	1992-10-30
K924133	Electrotrace, Modification	Jason Marketing Co.	DRX	Class II	1992-10-30
K923823	3D Imaging	Resonex, Inc.	LNH	Class II	1992-10-30
K923616	Omniflex-C Uhmwpe Mid-Shaft Restrictor	Osteonics Corp.	JDK	Class II	1992-10-30