Cleared Traditional

K854705 - INFAGUARD TM

K854705 is an FDA 510(k) clearance for INFAGUARD TM, manufactured by Lifewatch Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K854705 · Lifewatch Systems, Inc. · Anesthesiology device
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May 1986
Decision
161d
Days
Class 2
Risk

K854705 is an FDA 510(k) clearance for the INFAGUARD TM. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Lifewatch Systems, Inc. (Clackamas, US). The FDA issued a Cleared decision on May 1, 1986 after a review of 161 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 - K854705

510(k) Number K854705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date May 01, 1986
Days to Decision 161 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 140d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 128
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K854705.
INFANT MONITOR
K861484 · Healthdyne, Inc. · May 1986
NEO-TRAK 502 INFANT MONITOR
K861407 · Ge Medical Systems Information Technologies · May 1986
AS165 RESPIRATION MONITOR
K861743 · Air-Shields, Inc. · May 1986
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
K860455 · Oxford Medilog, Inc. · Apr 1986
HEALTHDYNE'S EVENT RECORDER SYSTEM
K860254 · Healthdyne, Inc. · Jan 1986
MONAGHAN RVM, MODEL 760 OR MODEL 761
K853047 · Monaghan Medical Corp. · Nov 1985
K854705 · INFAGUARD TM
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