Cleared Traditional

K831650 - ANESTHESIA/RESPIRATORY DISCONNECT -

K831650 is the FDA 510(k) clearance for ANESTHESIA/RESPIRATORY DISCONNECT - by Plasmedics, Inc.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K831650 · Plasmedics, Inc. · Anesthesiology device
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Sep 1983
Decision
112d
Days
Class 2
Risk

K831650 is an FDA 510(k) clearance for the ANESTHESIA/RESPIRATORY DISCONNECT -. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Plasmedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 112 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

Submission Details

510(k) Number K831650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date September 12, 1983
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K831650.
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · Nihon Kohden America, Inc. · Feb 1987
NEO-TRAK 502 INFANT MONITOR
K861407 · Ge Medical Systems Information Technologies · May 1986
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K812667 · Honeywell, Inc. · Oct 1981
NEO NATAL RESPIRATION FUNCTION BLOCK
K810175 · Honeywell, Inc. · Mar 1981