510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100104Substantially Equivalent

Hybernite Rainout Control System

Plastiflex Group NV, Claremont NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100104 is the FDA 510(k) clearance record for HYBERNITE RAINOUT CONTROL SYSTEM, a class II device, cleared for Plastiflex Group NV on under FDA product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer). FDA records list 2 510(k) clearances for Plastiflex Group NV, from to . As of , FDA records show no recalls naming K100104.

Clearance record

Decision date
Received
(91 days to decision)
Product code
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Regulation
21 CFR 868.5270
Device class
Class II
Review panel
Anesthesiology
Applicant
Plastiflex Group NV 220 River Rd., Claremont NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZE

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