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 2026-11-02, 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 987 of 3531

510(k) clearances, page 987 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101723	Compact Wheelchair Platform	Design Specific Fletcher	INO	Class II	2010-12-23
K101522	Ultra Seal Sterile Lubricating Jelly	Ultra Seal Corporation	KMJ	Class I	2010-12-23
K101427	Audit Microcv Hs-Crp Linearity Set	Aalto Scientific Ltd.	JJX	Class I	2010-12-23
K100715	Audit Microcv Homocysteine Linearity Set, Model 704M-5	Aalto Scientific Ltd.	JJX	Class I	2010-12-23
K094030	Fore-Sight Absolute Cerebral and Somatic Oximeter, Mc 2000 Series, Models Mc2000, Mc2010, Mc2020, Mc2030	Cas Medical Systems, Inc.	MUD	Class II	2010-12-23
K103568	Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh	MEDLINE INDUSTRIES, LP - Northfield	FTL	Class II	2010-12-22
K103466	Arthrex Univers II Shoulder Prosthesis	Arthrex GmbH	KWS	Class II	2010-12-22
K103464	Pacific Xtreme Ptca Balloon Dilatation Catheter	Medtronic, Inc.	LIT	Class II	2010-12-22
K103405	Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction Cath	Vascular Solutions LLC	QEZ	Class II	2010-12-22
K103109	Ponsky* Non-Balloon Replacement Gastrostomy Tube	C.R. Bard Inc	KNT	Class II	2010-12-22
K102992	T2 Recon Nail, R1500, Left/right 125 Degrees / 120 Degrees / 130 Degrees	Howmedica Osteonics Corp	HSB	Class II	2010-12-22
K102972	Lifepak 12	Physio Control, Inc.	MKJ	Class III	2010-12-22
K102808	Mi Varnish	GC America Inc.	LBH	Class II	2010-12-22
K102783	Hinson & Hale Medical Technologies Infused (R) Polyester Wrappers	Hinson and Hale Medical Technologies, Inc.	FRG	Class II	2010-12-22
K102764	Resolution II Clip	Boston Scientific Corporation	PKL	Class II	2010-12-22
K102710	Neo-Servo I	Atom Medical Corporation	FMZ	Class II	2010-12-22
K102605	Mahurkar Triple Lumen Dialysis Catheter	Covidien, LLC, Formerly Registered AS Tyco Healthca	NIE	Class II	2010-12-22
K102600	Simplygo Breast Pump	Evenflo Company, Inc.	HGX	Class II	2010-12-22
K102565	Anterior Approach Hip Surgery Instruments	Wrightmedicaltechnologyinc	KWA	Class III	2010-12-22
K102502	Golife Nasal Mask	Respironics, Inc.	BZD	Class II	2010-12-22
K102392	Microfuse Putty and Microfuse St Mis	Globus Medical, Inc.	MQV	Class II	2010-12-22
K102391	Bard Dignishield Stool Management System	C.R. Bard Inc	KNT	Class II	2010-12-22
K102350	Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	2010-12-22
K102348	31P/1h Dual Tuned Surface Coil 3T; 23Na/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual Turned Surface Coil 3T	Rapid Biomedical GmbH	MOS	Class II	2010-12-22
K102281	Thermal Massage Bed, Model 2D-Gx	Inarex Corporation	JFB	Class II	2010-12-22
K102054	V200 Ventilator	Respironics, Inc.	CBK	Class II	2010-12-22
K102027	Axis Nano Opthalmic Biometer Ultrasound System	Quantel Medical	IYO	Class II	2010-12-22
K102007	Prolong, Models Pl 18040Tc, Pl18050tgc, Pl18100tgc, Pl18150tgc,	Life-Tech, Inc.	CAZ	Class II	2010-12-22
K101861	Truevision 3D Visualization and Guidance System	Truevision Systems, Incorporated	HKI	Class II	2010-12-22
K101782	Microstaar Msi Injector System Cartridge	Staar Japan	MSS	Class I	2010-12-22
K101189	Reavillmed Pressure Monitoring System and Picc	Reavillmed	DRS	Class II	2010-12-22
K093715	Evok 900 Series Hearing Aid/tinnitus Masker Option Device	Magnatone Hearing Aid Corp. dba Persona Medical	KLW	Class II	2010-12-22
K103502	Cellsearch Circulating Tumor Cell Kit Model 7900001	Veridex, LLC	NQI	Class II	2010-12-21
K103223	Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts	Encore Medical, LP	OIY	Class II	2010-12-21
K103093	Leksell Gammaplan	Elekta Instrument AB	MUJ	Class II	2010-12-21
K102997	Sonixtablet Ultrasound Scanner	Ultrasonix Medical Corporation	IYN	Class II	2010-12-21
K102966	2.6F X 20Cm Vascu-Picc, 2.6F X 50Cm Vascu-Picc	Medcomp	LJS	Class II	2010-12-21
K102862	Neurovision Se (Nerveana)	Neurovision Medical Products Inc	ETN	Class II	2010-12-21
K102770	Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium Flow	Kulzer GmbH	ELW	Class II	2010-12-21
K102700	Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification Materials	Alere, San Diego, dba Biosite Incorporated, dba in	JJY	Class I	2010-12-21
K102549	The Ascension Movement Great Toe System Total Arthroplasty	Ascension Orthopedics, Inc.	LZJ	Unclassified	2010-12-21
K102410	Matryx Interference Screw (5.0-6.5Mm)	Conmed Linvatec	HWC	Class II	2010-12-21
K102242	Osom C. Difficile Toxin A/b Test	Genzyme Corporation	LLH	Class I	2010-12-21
K102057	Targon Fn System	Aesculap Inc	KTT	Class II	2010-12-21
K101982	Merlin Psa Patient Cable Ex 3150, Cable Adapter Ex3170, M Adapter Ex3180	Abbott Medical	DTA	Class II	2010-12-21
K101715	Fresenius 2008T Hemodialysis Machine Model 190573	Fresenius Medical Care North America, Design Cente	KDI	Class II	2010-12-21
K100937	Pc Care Blood Glucose Data Management Software	I-SENS, Inc.	NBW	Class II	2010-12-21
K100883	Carrigen	Etex Corp.	LYC	Class II	2010-12-21
K100790	Coulter Lin-X Linearity Control, Model A81196	Siemens Healthcare Diagnostics Inc.	JPK	Class II	2010-12-21
K100703	Stationary X-Ray System (Detector) Model: Altas	Comed Co., Ltd.	MQB	Class II	2010-12-21