Cleared Traditional

K951856 - HUMID-VENT MICRO

K951856 is an FDA 510(k) clearance for HUMID-VENT MICRO, manufactured by Gibeck, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K951856 · Gibeck, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
47d
Days
Class 1
Risk

K951856 is an FDA 510(k) clearance for the HUMID-VENT MICRO. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Gibeck, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 7, 1995 after a review of 47 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 - K951856

510(k) Number K951856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1995
Decision Date June 07, 1995
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 140d · This submission: 47d
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 62
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K951856.
HUMID-VENT FILTER PEDI
K952084 · Gibeck, Inc. · Jun 1995
DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME
K946209 · Med-Plastics Intl., Inc. · Jun 1995
FLEXLIFE
K952036 · Mallinckrodt Medical · Jun 1995
AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H
K945359 · Artema Medical AB · Feb 1995
FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT
K950447 · Vital Signs, Inc. · Feb 1995
DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER
K945657 · Tec II Medical, Inc. · Dec 1994
K951856 · HUMID-VENT MICRO
Download PDF FDA Summary Gibeck, Inc.