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 2274 of 3531

510(k) clearances, page 2274 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924335	Drapes	Pfb Inter-Apparel Corp.	KKX	Class II	1993-09-07
K923652	Dulbecco's Phosphate Buffered Saline	Life-Tech Intl., Inc.	MFD	Class II	1993-09-07
K923651	Distilled Water	Life-Tech Intl., Inc.	MFD	Class II	1993-09-07
K923634	Modified F-10 Culture Medium	Life-Tech Intl., Inc.	MFD	Class II	1993-09-07
K923612	Modified F-10 Culture Medium W/o Hypoxanthine	Life-Tech Intl., Inc.	MFD	Class II	1993-09-07
K922206	Surgistat	Medtronic, Inc.	HGI	Class II	1993-09-07
K914552	Cmi Vacuum Pump	Columbia Medical & Surgical, Inc.	HDA	Class II	1993-09-07
K933009	Surgical Retractor/blunt Dissector	Advanced Surgical, Inc.	GCJ	Class II	1993-09-03
K932799	Single Use Manual Resuscitator PEEP Valve	Engineered Medical Systems, LLC	BYE	Class II	1993-09-03
K932797	Pressure Limiting Elbow	Engineered Medical Systems, LLC	BTM	Class II	1993-09-03
K930751	Durham; Extension Tube Luer Lock W/injection Site	Intl. Medical Consultants	FPA	Class II	1993-09-03
K930750	Durham; Adm. Set-Luer Lock W/.22 Micron Filter	Intl. Medical Consultants	FPA	Class II	1993-09-03
K930559	Vitalmax 800-C	Pace Tech, Inc.	CCK	Class II	1993-09-03
K930410	Durham; Luer Lock Extension Set	Intl. Medical, Inc.	FPA	Class II	1993-09-03
K930406	Durham; Min Bore Luer Lock Extension Set	Intl. Medical, Inc.	FPA	Class II	1993-09-03
K930348	Combo Cath Wire-Guided Cytology System	Boston Scientific Corporation	FDX	Class II	1993-09-03
K930095	Spacelabs Medical Patient Monitor	GE Healthcare	DSI	Class II	1993-09-03
K926123	Dual Chamber Mixing Bag	Secure Medical, Inc.	KPE	Class II	1993-09-03
K925382	Cutter, Surgical	Mectra Laboratories, Inc.	GCJ	Class II	1993-09-03
K924163	Explorer/360-Polaris-L.e./jackman Coron Sinus Elec	Boston Scientific Corporation	DRF	Class II	1993-09-03
K923755	Flex Finder Guidewire	Flex Medics Corporation	OCY	Class II	1993-09-03
K922245	Super-Flow Tubing	Armm, Inc.	HIF	Class II	1993-09-03
K914430	Natracare Tampon	Bodywise (UK) Ltd.	HEB	Class II	1993-09-03
K911432	Accellon Cervical Biosampler	Medscand AB	HHT	Class II	1993-09-03
K930235	Hemochron/factor VI Whole Blood Factor VIII Assay	Technidyne Corp.	GGP	Class II	1993-09-02
K930068	Hemochron Model 8000/Factor VI Premier Coagulation	Technidyne Corp.	JPA	Class II	1993-09-02
K925508	Rusch Safety Clear Plus Cuffed W/magill Tip	Rusch, Inc.	BTR	Class II	1993-09-02
K925507	Rusch Safety Clear Uncuffed with Magill Tip	Rusch, Inc.	BTR	Class II	1993-09-02
K925505	Rusch Safety Clear Plus Cuffed W/murphy Eye	Rusch, Inc.	BTR	Class II	1993-09-02
K924935	Hard Tissue Replace(htr(r))-Patient-Match Implant	Polyclinic Medical Center	KKY	Class II	1993-09-02
K922799	Capiox Sx Hollow Fiber Oxygenator	Terumo Medical Corp.	DTZ	Class II	1993-09-02
K932801	Cardima Seeker and Stubbie Guidewires	Cardima, Inc.	DQX	Class II	1993-09-01
K932788	Cordis Bipal 7 Biopsy Forceps with a Inline Handle	Cordis US Corp.	DWZ	Class II	1993-09-01
K931980	Stainless Steel Orthodontic Products	Ortho Organizers Inc	DYO	Class I	1993-09-01
K931375	Abbott Plum Xl Infusion Pump	Abbott Medical	FRN	Class II	1993-09-01
K931198	Uniquet	Icat Systems	GAX	Class I	1993-09-01
K930850	Beckman Vigil Plus Control	Beckman Instruments, Inc.	JJY	Class I	1993-09-01
K930409	Pmt(r) Silicone Gel Sheeting Model 3505-1	PMT Corp.	MDA	Class I	1993-09-01
K930312	3M Red Dot 2234 Radiolucent Monitoring Electrode	3M Company	DRX	Class II	1993-09-01
K925224	U108, U105, G209-B	Custom Optical Frames, Inc.	HQY	Class I	1993-09-01
K925159	Tof-Guard Transmission Monitor	Biometer Intl. A/S	KOI	Class II	1993-09-01
K923790	Facsort Flow Cytometer	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1993-09-01
K922889	Condoom Shelf Life -- Modifications	Safetex Corp.	HIS	Class II	1993-09-01
K922834	Tampons, Natural Odor Prot. Various Absorbency	Playtex Family Products, Inc.	HIL	Class II	1993-09-01
K914419	Amniotest(tm)	Pro-Lab, Inc.	HIO	Class I	1993-09-01
K933280	Spectacle Frames	U.S. Optical	HQZ	Class I	1993-08-31
K932906	Spectacle Frames	U.S. Optics, Inc.	HQZ	Class I	1993-08-31
K932813	Frames, Spectacle	Rainbow Optics, Inc.	HQZ	Class I	1993-08-31
K932762	10.0Mm Suction/irrigation Probe & Tubing Kit	Inman Medical Corp.	GCS	Class II	1993-08-31
K931744	Olympus Reply Glucose Reagent	Olympus Corp.	JJE	Class I	1993-08-31