Cleared Traditional

K923865 - 5701

K923865 is the FDA 510(k) clearance for 5701 by Vital Signs, Inc.. It is a Class 1 Anesthesiology device (product code BYD) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K923865 · Vital Signs, Inc. · Anesthesiology device
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Feb 1993
Decision
182d
Days
Class 1
Risk

K923865 is an FDA 510(k) clearance for the 5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on February 1, 1993 after a review of 182 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.

View all Vital Signs, Inc. devices

Submission Details

510(k) Number K923865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1992
Decision Date February 01, 1993
Days to Decision 182 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 140d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 23
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K923865.
TRACHEOLIFE
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K922946 · Mallinckrodt Medical · Mar 1993
BREATHE EASY
K914336 · Vital Signs, Inc. · Mar 1992
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
K903519 · Intertech Resources, Inc. · Dec 1990
HUMIDI-FLEX TM
K885313 · Life Design Systems, Inc. · Oct 1989