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 1267 of 3531

510(k) clearances, page 1267 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060549	Automobile Lighter Power Cord	Pulmonetic Systems, Inc.	CBK	Class II	2006-05-04
K060369	Stratus Cs Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak	Siemens Healthcare Diagnostics Inc.	NQD	Class II	2006-05-04
K060295	Carbon Dioxide	Abbott Medical	KHS	Class II	2006-05-04
K060271	Spiralok Anchor	DePuy Mitek, Inc.	HWC	Class II	2006-05-04
K060129	Igs Vaginal Speculum	Innovative Gynecological Solutions, LLC	HIB	Class II	2006-05-04
K060065	Capnostream20 Two Parameter Bedside Monitor & Capnostream10 One Parameter Bedside Monitor	Oridion Capnography, Inc.	DQA	Class II	2006-05-04
K053546	Sonicator 740, Model Me 740	Mettler Electronics Corp	IMI	Class II	2006-05-04
K053234	Pm-9000 Express Patient Monitor	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MWI	Class II	2006-05-04
K053188	Reprocessed Baloon Inflation Device	Sterilmed Inc	NKU	Class II	2006-05-04
K053111	Sta-Cephascreen Kit	Diagnostica Stago, Inc.	GFO	Class II	2006-05-04
K052392	Hot Dog Patient Warming System	Augustine Biomedical & Design, LLC	DWJ	Class II	2006-05-04
K052371	Depilite El-8B Series Dermo Flash Systems	Hair International Systems USA, Inc.	GEX	Class II	2006-05-04
K061104	Speechlink 100 Type 1053	Natus Medical Denmark ApS	ETW	Class II	2006-05-03
K061068	Eg-3670Urk	PENTAX of America, Inc.	ODG	Class II	2006-05-03
K060993	Ge Logiq P5 and A5	General Electric Co.	IYN	Class II	2006-05-03
K060867	Spy Intraoperative Imaging System	Novadaq Technologies ULC	IZI	Class II	2006-05-03
K060742	Legion Cobalt Chrome Revision Knee System	Smith & Nephew, Inc.	JWH	Class II	2006-05-03
K060585	Roche Elecsys- Acth,acth Calset,acth Calcheck,precicontrol Acth	Roche Diagnostics GmbH	CKG	Class II	2006-05-03
K060574	Total Bilirubin	Abbott Medical	CIG	Class II	2006-05-03
K060353	Acro Rapid Phencyclidine Urine Test, Catalog Pcp001000	ACRO BIOTECH Inc.	LCM	Unclassified	2006-05-03
K060287	Drilltech, Ism, Implantunit, Zimmer Surgical Motor System	W & H DentalWerk Buermoos GmbH	EBW	Class I	2006-05-03
K060275	Piezotome	Satelec	ELC	Class II	2006-05-03
K052771	Sensor Walk	Otto Bock Healthcare LP	IQI	Class I	2006-05-03
K052639	Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer	Biomet Manufacturing Corp	JDI	Class II	2006-05-03
K061009	Pathway Balloon Expandable Ureteral Access Sheath, Model Beus	Onset Medical Corporation	EZN	Class II	2006-05-02
K060931	Hemosil Pt-Fibrinogen Hs Plus	Instrumentation Laboratory Co.	GJS	Class II	2006-05-02
K060894	Bifix Qm	Voco GmbH	EMA	Class II	2006-05-02
K060803	G.usbamp	G.tec Medical Engineering GmbH	GWL	Class II	2006-05-02
K060799	Cosman Csk RF Cannula; Cosman Rfk RF Cannula	Boston Scientific Neuromodulation Corporation	GXI	Class II	2006-05-02
K060554	Cma Cerebral Tissue Monitoring System	Cma Microdialysis AB	GWM	Class II	2006-05-02
K060380	Fidis Dsdna	Biomedical Diagnostics (Bmd) SA	LSW	Class II	2006-05-02
K060273	Sleepnet Mojo Full Face Mask -Small, Model No. 53835, Medium ,Model No.53836,large,model No. 53837	SleepNet Corporation	BZD	Class II	2006-05-02
K053333	Eaglevision Gellanserts, Model Ref 0040	Grace Medical, Inc.	LZU	Unclassified	2006-05-02
K053052	Medela Swing Breast Pump	Medela AG	HGX	Class II	2006-05-02
K052824	Kimberly-Clark Procedure Gown	Kimberly-Clark Corporation	FYA	Class II	2006-05-02
K061029	Jetstream Workspace	Philips North America LLC	LLZ	Class II	2006-05-01
K060961	15-Inch (38Cm) Color Lcd Monitor Cdl1566a	Totoku Electric Co., Ltd.	LLZ	Class II	2006-05-01
K060784	Synthetic Vinyl Patient Examination Glove-Powered	Ever Light Plastic Products Co., Ltd.	LYZ	Class I	2006-05-01
K060771	Powder-Free Nitrile Patient Examination Glove,white (Non-Colored) and Blue Colored	Kossan Latex Industries (M) Sdn Bhd	LZA	Class I	2006-05-01
K060728	Novabone Putty - Bioactive Synthetic Graft	Novabone Products, LLC	MQV	Class II	2006-05-01
K060633	Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0	Siemens Medical Solutions USA, Inc.	IYE	Class II	2006-05-01
K060274	Piezotome	Satelec	DZI	Class II	2006-05-01
K060073	Textured Powder Free Nitrile Exam Gloves (Black Color), Chemo Labeling	Shen Wei (USA), Inc.	LZA	Class I	2006-05-01
K052708	Pylo-Plus	Arj Medical, Inc.	LYR	Class I	2006-05-01
K061021	Entake Standard and Safety Peg System	Conmedcorp	KNT	Class II	2006-04-28
K061018	Planar Dome Ex Line Model Dome E2c	Planar Systems, Inc.	LLZ	Class II	2006-04-28
K060992	Syngo US Workplace	Siemens Medical Solutions	LLZ	Class II	2006-04-28
K060935	Synchron Systems Creatinine (Crea) Reagent	Siemens Healthcare Diagnostics Inc.	CGX	Class II	2006-04-28
K060929	Immulite 2500 Vitamin B12 Model L5kvb2-200 Test,l5kvb6-600 Test, Immulite 2500 Folic Acid Model L5kfo2-200 Test,l5kfo6-6	Siemens Healthcare Diagnostics Inc.	CDD	Class II	2006-04-28
K060904	Cleaner Rotational Thrombectomy System	Rex Medical LP	MCW	Class II	2006-04-28