510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K152201Substantially Equivalent

MedActive Oral Gel and Spray

Medactive Oral Pharmaceuticals, LLC, Odessa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152201 is the FDA 510(k) clearance record for MedActive Oral Gel and Spray, cleared for Medactive Oral Pharmaceuticals, LLC on under FDA product code LFD (Saliva, Artificial). FDA records list one 510(k) clearance for Medactive Oral Pharmaceuticals, LLC. As of , FDA records show no recalls naming K152201.

Clearance record

Decision date
Received
(146 days to decision)
Product code
LFD Saliva, Artificial
Device class
Unclassified
Review panel
Unknown
Applicant
Medactive Oral Pharmaceuticals, LLC 1900 Gunn Hwy., Odessa FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFD

Trailing 12 months
1 clearance under product code LFD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260