Cleared Traditional

K881656 - HUMID-VENT 2 S FLEX

K881656 is an FDA 510(k) clearance for HUMID-VENT 2 S FLEX, manufactured by Gibeck Respiration. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K881656 · Gibeck Respiration · Anesthesiology device
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Jun 1988
Decision
62d
Days
Class 1
Risk

K881656 is an FDA 510(k) clearance for the HUMID-VENT 2 S FLEX. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Gibeck Respiration (Schaumburg, US). The FDA issued a Cleared decision on June 16, 1988 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K881656

510(k) Number K881656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1988
Decision Date June 16, 1988
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 140d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

All 57
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K881656.
HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE
K900150 · Icor AB · Jan 1990
HUMIDI-FLEX TM
K885313 · Life Design Systems, Inc. · Oct 1989
FLOCARE
K893875 · Mega-Tech Intl., Inc. · Aug 1989
THERMOVENT 600, 1200, T, 02
K874597 · Portex, Inc. · Jan 1988
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
K864095 · Gambro, Inc. · Feb 1987
AMERICAN PHARMASEAL HUMIDAIR CONDENSER
K854012 · American Pharmaseal Div. Ahsc · Dec 1985
K881656 · HUMID-VENT 2 S FLEX
Download PDF Gibeck Respiration