510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913527Substantially Equivalent

Hyperfree

Kist Intl., Lewiston ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913527 is the FDA 510(k) clearance record for HYPERFREE, a class I device, cleared for Kist Intl. on under FDA product code BYO (Bottle, Blow). FDA records list one 510(k) clearance for Kist Intl. As of , FDA records show no recalls naming K913527.

Clearance record

Decision date
Received
(166 days to decision)
Product code
BYO Bottle, Blow
Regulation
21 CFR 868.5220
Device class
Class I
Review panel
Anesthesiology
Applicant
Kist Intl. 550 Lisbon St., Lewiston ME
510(k) summary
Statement
Third party review
No

Clearances, product code BYO

Trailing 12 months

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

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