Cleared Traditional

K831601 - APNEA ALARM FOR ADULT-PEDIATRIC & NEON

K831601 is an FDA 510(k) clearance for APNEA ALARM FOR ADULT-PEDIATRIC & NEON, manufactured by Plasmedics, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K831601 · Plasmedics, Inc. · Anesthesiology device
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Sep 1983
Decision
131d
Days
Class 2
Risk

K831601 is an FDA 510(k) clearance for the APNEA ALARM FOR ADULT-PEDIATRIC & NEON. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Plasmedics, Inc. (Walker, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 131 days - within the typical 510(k) review window.

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.

View all Plasmedics, Inc. devices

FDA 510(k) Submission Details - K831601

510(k) Number K831601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1983
Decision Date September 26, 1983
Days to Decision 131 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 140d · This submission: 131d
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 113
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K831601.
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
RESPIRATION & HEART RATE MONITOR 530
K843681 · Tri-Med, Inc. · Dec 1984
INFANT MONITOR 16900
K843546 · Healthdyne, Inc. · Oct 1984
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983
TRIMED 510 APNEA MONITOR
K822819 · Tri-Med, Inc. · Nov 1982
HEALTHDYNE MODEL 16900 INFANT MONITOR
K821731 · Healthdyne, Inc. · Jul 1982