510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881516Substantially Equivalent

Compresaid

R. Evans Corp., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881516 is the FDA 510(k) clearance record for COMPRESAID, a class I device, cleared for R. Evans Corp. on under FDA product code FZF (Splint, Extremity, Inflatable, External). FDA records list one 510(k) clearance for R. Evans Corp. As of , FDA records show no recalls naming K881516.

Clearance record

Decision date
Received
(18 days to decision)
Product code
FZF Splint, Extremity, Inflatable, External
Regulation
21 CFR 878.3900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
R. Evans Corp. Suite 209, Phoenix AZ
Third party review
No

Clearances, product code FZF

Trailing 12 months

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

FDA records show no clearances under product code FZF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZF, 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