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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3135 of 3528

510(k) clearances, page 3135 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832069	Toxo Ipa Kit Ian Indirect Fluorescent	Bionetic Laboratory Products	LJK	Class II	1983-09-26
K831991	Directigen Group B Strep Test Kit-Serum	BD Becton Dickinson Vacutainer Systems Preanalytic	GTZ	Class I	1983-09-26
K831930	Toxo-Screen Da Test	BD Becton Dickinson Vacutainer Systems Preanalytic	LLA	Class II	1983-09-26
K831917	Vilene Cotton Gauze II	Hall-Tech	EFQ	Unclassified	1983-09-26
K831913	Color-Eze Pre-Washed Lap Sponges	Ormed Mfg., Inc.	GDY	Class I	1983-09-26
K831887	Bactigen S. Pneumoniae	Armkel, LLC	GWC	Class I	1983-09-26
K831856	Breathing Circuit Bacteria Filter	Vital Signs, Inc.	CAH	Class II	1983-09-26
K831842	Dravon T Clamp	Dravon Medical, Inc.	KDC	Class I	1983-09-26
K831663	Tissue Forceps	Medcare Products	KOC	Class II	1983-09-26
K831601	Apnea Alarm for Adult-Pediatric & Neon	Plasmedics, Inc.	BZQ	Class II	1983-09-26
K830001	Superjet Btd Bleeding Time Device Disp	Medprobe Laboratories	FMK	Class II	1983-09-26
K832811	Shiley 3L Cardf Plus	Shiley, Inc.	DTP	Class II	1983-09-20
K832804	Sesam Table	Electro-Med Health Industries, Inc.	INQ	Class I	1983-09-20
K832803	Steam Pak Moist Heat	Electro-Med Health Industries, Inc.	IMA	Class I	1983-09-20
K832768	S & W Sw52e W/power Back Lift	S & W Enterprises, Inc.	LGX	Class I	1983-09-20
K832745	Oc3 Flyer	Intl. Medical Equipment Corp.	ITI	Class II	1983-09-20
K832742	Extension Control Knee Orthosis	Orthomedics	ITM	Class I	1983-09-20
K832741	Jason Cervical Orthosis	Orthomedics	IQF	Class I	1983-09-20
K832740	Femoral Fracture Orthosis	Orthomedics			1983-09-20
K832727	Mobie	Everest & Jennings, Inc.	INI	Class II	1983-09-20
K832725	Dual Dial Venturi Style Mask	Airlife, Inc.	BYF	Class I	1983-09-20
K832696	Riser Standup Wheelchair	Imex Medical Systems, Inc.	IPL	Class II	1983-09-20
K832685	Wheelchair-Various Models	Health America	IOR	Class I	1983-09-20
K832659	Biospal 1200S	Hospal Medical Corp.	KDI	Class II	1983-09-20
K832648	Acclaim	Electro-Nucleonics Laboratories, Inc.	JJE	Class I	1983-09-20
K832645	Biospal 3000 S	Hospal Medical Corp.	KDI	Class II	1983-09-20
K832629	Intubation Kit	Calbio, Inc.	BTR	Class II	1983-09-20
K832599	Early in Home Pregnancy Test	Warner-Lambert Co.	JHJ	Class II	1983-09-20
K832594	Pre-Bypass Filter #Ec-Pbf Series	Gish Biomedical, Inc.	KRJ	Class II	1983-09-20
K832553	Potassium Test Kit	Mallinckrodt Critical Care	CEJ	Class II	1983-09-20
K832552	Sodium Test Kit	Mallinckrodt Critical Care	CEI	Class II	1983-09-20
K832492	Broncho Fiberscope Fb-19C	Pentax Precision Instrument Corp.	EOQ	Class II	1983-09-20
K832481	Scleral Buckling Implants Dif/types	Storz Instrument Co.	HQX	Class II	1983-09-20
K832472	Elevator Cushion	Inmed Corp.	FWZ	Class I	1983-09-20
K832449	Laryngotelescope Curved Mlc-1	Pentax Precision Instrument Corp.	EOQ	Class II	1983-09-20
K832434	Hbo-1 Pass-Through/extension Tube	Nauset Labs	FPA	Class II	1983-09-20
K832218	Allergen Control Inhalent	Ventrex Laboratories, Inc.	DGC	Class II	1983-09-20
K832217	Ventre/spec Allergen Control-Molds/food	Ventrex Laboratories, Inc.	DHB	Class II	1983-09-20
K832132	Sera-Tek Mycoplasma Antibody Test	Miles Laboratories, Inc.	GSB	Class I	1983-09-20
K831982	Bradford Spinal Fracture Fixation Sys	Depuy, Inc.	KWQ	Class II	1983-09-20
K831972	Epsilon Tsh Test Kit	Beckman Instruments, Inc.	JLW	Class II	1983-09-20
K831884	Spectron Extra-Small, Straight Femoral	Richards Manufacturer Co.	JDI	Class II	1983-09-20
K831882	Posidyne Solution Container Filter	Pall Biomedical Products Co.	FPB	Class II	1983-09-20
K831504	Herpes Ident. & Typing Test Hitt	Electro-Nucleonics Laboratories, Inc.	GQL	Class II	1983-09-20
K831420	Hip Prosthesis -Various	The Oec Group	KWL	Class II	1983-09-20
K832526	Urotrack Plus	Vital Metrics, Inc.	KNX	Class II	1983-09-19
K832389	Catheter Care Tray	Inmed Corp.	KOD	Class II	1983-09-19
K832370	Egs Model 100-2	Electro-Med Health Industries, Inc.			1983-09-16
K830657	Ambulatory Mark XI Drug Infusion Dev-	Windsor Medical, Inc.	FRN	Class II	1983-09-16
K832788	Infuse-a-Port	Infusaid Corp.	LJT	Class II	1983-09-15