Cleared Traditional

K885313 - HUMIDI-FLEX TM

K885313 is an FDA 510(k) clearance for HUMIDI-FLEX TM, manufactured by Life Design Systems, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K885313 · Life Design Systems, Inc. · Anesthesiology device
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Oct 1989
Decision
286d
Days
Class 1
Risk

K885313 is an FDA 510(k) clearance for the HUMIDI-FLEX TM. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Life Design Systems, Inc. (Franklin, US). The FDA issued a Cleared decision on October 11, 1989 after a review of 286 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K885313

510(k) Number K885313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1988
Decision Date October 11, 1989
Days to Decision 286 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 140d · This submission: 286d
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 56
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K885313.
HME-10 (TM)
K903054 · Pharma Systems, Inc. · Oct 1990
FLOCARE N
K902501 · Flocare Medical · Jul 1990
HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE
K900150 · Icor AB · Jan 1990
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
K885313 · HUMIDI-FLEX TM
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