510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K953505Substantially Equivalent for Some Indications

Burnaid Burn First Aid Dressing

Rye Pharmaceuticals Pty., Ltd., Petaluma CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K953505 is the FDA 510(k) clearance record for BURNAID BURN FIRST AID DRESSING, cleared for Rye Pharmaceuticals Pty. , Ltd. on under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic). FDA records list one 510(k) clearance for Rye Pharmaceuticals Pty. , Ltd. As of , FDA records show no recalls naming K953505.

Clearance record

Decision date
Received
(198 days to decision)
Product code
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified
Review panel
Unknown
Applicant
Rye Pharmaceuticals Pty. , Ltd. 916 Catalpa Way, Petaluma CA
Third party review
No

Clearances, product code MGQ

Trailing 12 months

FDA records hold no clearances under product code MGQ in the trailing twelve months.

FDA records show no clearances under product code MGQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MGQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260