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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 577 of 3529

510(k) clearances, page 577 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K171595	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	Medacta International SA	OUR	Class II	2017-08-02
K171172	Skyn Original Polyisoprene Lubricated Male Condom - Flavored	Ansell Healthcare Products LLC	MOL	Class II	2017-08-02
K171038	Hearing Healthcare Pro	Db Diagnostic Systems, Inc.	ETY	Class II	2017-08-02
K170712	Accutorr 7/VS-900 Vital Signs Monitor	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	MWI	Class II	2017-08-02
K170651	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	Yangzhou Medline Industry Co., Ltd.	MEG	Class II	2017-08-02
K163704	Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card	Healgen Scientific LLC	JXM	Class II	2017-08-02
K162832	731 Series Ventilators	ZOLL Medical Corporation	CBK	Class II	2017-08-02
K171975	HardyDisk AST Delafloxacin 5 µg (DLX5)	Hardy Diagnostics	JTN	Class II	2017-08-01
K171906	Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL	Liofilchem S.r.l.	JWY	Class II	2017-08-01
K171870	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL	Thermo Fisher Scientific Oy	JWY	Class II	2017-08-01
K171758	M.U.S.T. Combined Set Screws	Medacta International SA	NKB	Class II	2017-08-01
K171639	Trojan Supra Lubricated Polyurethane Male Condom	Church & Dwight Co., Inc.	MOL	Class II	2017-08-01
K171619	14Fr Colon Decompression Set, Macon Colon Decompression Set	Cook Ireland Ltd.	FEG	Class II	2017-08-01
K171369	M.U.S.T. MINI Posterior Cervical Screws System	Medacta International SA	NKG	Class II	2017-08-01
K171315	Advanced RBC Application	Cellavision AB	JOY	Class II	2017-08-01
K171079	Q-Switched Nd:YAG Laser System	Ids, Ltd.	GEX	Class II	2017-08-01
K171077	HEXA100 (hexafocon A) Daily Wear Contact Lenses	Contamac Ltd.	HQD	Class II	2017-08-01
K171075	Calix-C Cervical Interbody Spacer	Xtant Medical Holdings, Inc.	ODP	Class II	2017-08-01
K171062	BP5S Wireless Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2017-08-01
K170894	Zirconia Dental Ceramics	Chengdu Besmile Biotechnology Co., Ltd.	EIH	Class II	2017-08-01
K170885	DD cubeX2 HS	Dental Direkt GmbH	EIH	Class II	2017-08-01
K170565	LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L	Lifewatch Services, Inc.	QYX	Class II	2017-08-01
K170285	AED Sinuscope	National Advanced Endoscopy Devices, Inc.	EOB	Class II	2017-08-01
K172025	Litho 60	Quanta System Inc.	GEX	Class II	2017-07-31
K171999	Performer Introducer	Cook Incorporated	DYB	Class II	2017-07-31
K171623	Nasal Pancreatic Drainage Set	Cook Ireland Ltd.	FGE	Class II	2017-07-31
K171615	Xingyu Nitrile Powder Free Patient Examination Gloves, White color	Shandong Xingyu Gloves Co., Ltd	LZA	Class I	2017-07-31
K171607	Bronchi and Gastrointestinal Cytology Brush	Wilson-Cook Medical Inc./Cook Endoscopy	FDX	Class II	2017-07-31
K171588	NuBODY Skin Toning Device	Carol Cole Company dba NuFACE	NFO	Class II	2017-07-31
K171301	Scanmate Flex	DGH Technology, Inc.	IYO	Class II	2017-07-31
K171132	Carefusion NeutraClear Needle-free connector	Cair LGL	FPA	Class II	2017-07-31
K171040	Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range	Koelis	ITX	Class II	2017-07-31
K170842	Wego-PTFE	Foosin Medical Supplies Inc., Ltd.	NBY	Class II	2017-07-31
K170207	Obturys	Itena Clinical	KIF	Class II	2017-07-31
K163598	Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator	Advanced Sterilization Products	KCT	Class II	2017-07-31
K163136	Youha electric breast pump	Ningbo Youhe Electrical Appliance Technology Co., Ltd.	HGX	Class II	2017-07-31
K163127	bellavista 1000	Imtmedical AG	CBK	Class II	2017-07-31
K161845	Electronic Blood Pressure Monitor	Shenzhen Pango Electronic Co., Ltd.	DXN	Class II	2017-07-31
K172013	VitalBeam	Varian Medical Systems, Inc.	IYE	Class II	2017-07-28
K171945	Discovery Pico, Discovery Pico Plus	Quanta System Inc.	GEX	Class II	2017-07-28
K171754	NovaPACS	Novarad Corp.	LLZ	Class II	2017-07-28
K171699	da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2017-07-28
K171602	Williams Cystoscopic Injection Needle	Cook Incorporated	FBK	Class II	2017-07-28
K171265	Otowave 302 Portable Tympanometer	Amplivox Ltd	NAS	Class II	2017-07-28
K171103	Lumipulse G TSH-III Immunoreaction Cartridges	Fujirebio Diagnostics, Inc.	JLW	Class II	2017-07-28
K171054	Biomet Knee Joint Replacement Prostheses	Zimmer GmbH	JWH	Class II	2017-07-28
K170187	Photodynamic Therapy Device	Uvbiotek, LLC	GEX	Class II	2017-07-28
K163633	cobas HbA1c Test, cobas b 101 system	Roche Diagnostics GmbH	LCP	Class II	2017-07-28
K163352	Wheelchair	Kunshan Hi-Fortune Health Products Co., Ltd.	IOR	Class I	2017-07-28
K163259	AXS Offset Delivery Assist Catheter	Stryker Corp.	DQY	Class II	2017-07-28