510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920554Substantially Equivalent

Kold Wrap Sterile Burn Dressing

Kold Products, Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920554 is the FDA 510(k) clearance record for KOLD WRAP STERILE BURN DRESSING, cleared for Kold Products on under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic). FDA records list 2 510(k) clearances for Kold Products, from to . As of , FDA records show no recalls naming K920554.

Clearance record

Decision date
Received
(379 days to decision)
Product code
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified
Review panel
Unknown
Applicant
Kold Products 2026 Sterling Ave., Elkhart IN
510(k) summary
Statement
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