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 928 of 3530

510(k) clearances, page 928 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112583	Synthes Cortical Screws	Synthes (USA) Products LLC	HWC	Class II	2011-12-05
K112125	Illumigene Group B Streptococcus ,External Control Kit	Meridian Bioscience Inc	NJR	Class I	2011-12-05
K111811	Bendini(tm) Spinal Rod Bending System	NuVasive Inc	OLO	Class II	2011-12-05
K111732	Aquamantys Sbs 5.0 Sheated Biopolar Sealer	Salient Surgical Technologies, Inc.	GEI	Class II	2011-12-05
K111667	Synthes Suprapatellar Insertion Instruments	Synthes (USA) Products LLC	JDS	Class II	2011-12-05
K113428	Angiojet Ultra Dvx Thrombectomy Set	Medrad, Inc.	QEZ	Class II	2011-12-02
K113267	Biopmedics52,52 1Day,52 Toric,52 1Day Toric	CooperVision, Inc.	LPL	Class II	2011-12-02
K113245	Avaira Avaira Toric Avaira Multifocal	CooperVision, Inc.	LPL	Class II	2011-12-02
K113235	Pressure Display Box,dlp Disposable Pressure Display Sets-Non Sterile Versions	Medtronic, Inc.	DXS	Class II	2011-12-02
K113143	Immulisa Sci-70 Antibody Elisa	Immco Diagnostics, Inc.	LLL	Class II	2011-12-02
K112930	Mobile Mim	MIM Software Inc	LLZ	Class II	2011-12-02
K112779	Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)	Omnlife Science	LPH	Class II	2011-12-02
K112559	Medapps 2.0 Remote Patient Monitoring System	Medapps, Inc.	DRG	Class II	2011-12-02
K112003	Vantage Titan Hsr	Toshibamedical Systems Corporation	LNH	Class II	2011-12-02
K111922	Vocare Myhealth Tablet	Vocare, Inc.	DRG	Class II	2011-12-02
K111915	Magnesium Assay	Sekisui Diagnostics P.E.I. Inc.	JGJ	Class I	2011-12-02
K111907	Dynamic Du Series Portable Dental Unit	Shanghai Dynamic Industry Co., Ltd.	EIA	Class I	2011-12-02
K111751	Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44Mm Angled Loop Electrode, Versapoint II Footswitch, Vers	Ethicon, Inc	HIN	Class II	2011-12-02
K110786	Esensor Warfarin Sensitivity Saliva Test	Genmark Diagnostics, Inc.	NSU	Class II	2011-12-02
K110701	Oragene-Dx Ogd-500; Oragene-Dx Ogd-575; Oragene-Dx Oxd-525; Oragene-Dx Oyd-500	DNA Genotek Inc.	OYJ	Class II	2011-12-02
K110615	Water Filled Teether, Water Filled Teether with Handle	Bebe Toys Manufactory, Ltd.	KKO	Class II	2011-12-02
K113228	Renaissance System	Mazor Robotics Ltd	HAW	Class II	2011-12-01
K113201	Narval Cc	Resmed SAS	LQZ	Class II	2011-12-01
K113032	Snap Wound Care System	Spiracur, Inc.	OKO	Class II	2011-12-01
K112979	Asahi Chikai 10 Neurovascular Guide Wire	Asahi Intecc Co., Ltd.	MOF	Class II	2011-12-01
K112813	Amsco V-Pro	STERIS Corporation	MLR	Class II	2011-12-01
K112806	Jensen Zirconia	Jensen Industries, Inc.	EIH	Class II	2011-12-01
K112782	Misonix Sonicone(r) Ultrasonic Wound Care System and Accessories	Misonix, LLC	NRB	Class II	2011-12-01
K112337	Randox Liquid Immunoassay Premium Controls, Level 1, Level2, Level 3 and Tri Level	Randox Laboratories, Limited	JJY	Class I	2011-12-01
K112296	Lateral Button	T.A.G. Medical Products Corporation Ltd	MBI	Class II	2011-12-01
K112181	Hydrocoil(r) Embolic System (Hes)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2011-12-01
K112138	Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant	Astra Tech, Inc.	NHA	Class II	2011-12-01
K112126	Genuine First Aid CPR Mask	Genuine First Aid, LLC	CBP	Class II	2011-12-01
K112095	Acculif Tl-Peek Ibf Cage	Coalign Innovations, Inc.	MAX	Class II	2011-12-01
K112082	Guideliner V2 Catheter	Vascular Solutions LLC	DQY	Class II	2011-12-01
K111458	Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment Covers	Gri Medical & Electronic Technology Co., Ltd.	KKX	Class II	2011-12-01
K111335	St Aia-Pack Acth, and St Aia-Pack Acth Calibrator Set Model 025221 and 025321	Tosoh Bioscience Inc	CKG	Class II	2011-12-01
K111248	Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)	Yty Industry (Manjung) Sdn. Bhd.	LZA	Class I	2011-12-01
K111146	Newport Ht70 Ventilator	Newport Medical Instruments, Inc.	CBK	Class II	2011-12-01
K103531	Prestige 24I; Biolis 24I; Mgc 240	Tokyo Boeki Medisys, Inc.	CFR	Class II	2011-12-01
K101257	Advanced Trauma Dressing (Atd)	Nanosys, Inc.	QSY	Unclassified	2011-12-01
K112697	Charger Pta Ballon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	2011-11-30
K112570	Centricity Cardio Imaging	GE Healthcare	LLZ	Class II	2011-11-30
K112361	Alamo C	Alliance Partners, LLC	ODP	Class II	2011-11-30
K112354	5Mp Monochrome Lcd Monitor, Radiforce Gx530	Eizo Nanao Corporation	LLZ	Class II	2011-11-30
K111771	Non-Contact Tear Film Thermogragh	United Integrated Services Co., Ltd.	HKI	Class II	2011-11-30
K111655	Flaatz 760	DRTECH Corporation	KPR	Class II	2011-11-30
K110424	Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile Port- Attachable; Dignity Low Profil	Medcomp ( Medical Components)	LJT	Class II	2011-11-30
K110106	Vitek 2 Gram Negative Trimethoprim/sulfamethoazole	bioMerieux, Inc.	LON	Class II	2011-11-30
K103418	Desara Mini	Caldera Medical, Inc.	PAH	Class II	2011-11-30