Cleared Traditional

K884959 - RESPITRAK

K884959 is an FDA 510(k) clearance for RESPITRAK, manufactured by Non-Invasive Monitoring Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K884959 · Non-Invasive Monitoring Systems, Inc. · Anesthesiology device
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Jun 1989
Decision
191d
Days
Class 2
Risk

K884959 is an FDA 510(k) clearance for the RESPITRAK. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Non-Invasive Monitoring Systems, Inc. (Washington, US). The FDA issued a Cleared decision on June 8, 1989 after a review of 191 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 Non-Invasive Monitoring Systems, Inc. devices

FDA 510(k) Submission Details - K884959

510(k) Number K884959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1988
Decision Date June 08, 1989
Days to Decision 191 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 140d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZK Device Classification - Class 2, Special Controls

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 31
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K884959.
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K932098 · Datex Division Instrumentarium Corp. · Nov 1993
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
K931542 · Newport Medical Instruments, Inc. · Oct 1993
PARTNER VOLUME MONITOR
K901885 · Bird Products Corp. · Sep 1990
MONAGHAN RVM, MODEL 761
K884942 · Monaghan Medical Corp. · Jun 1989
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K890724 · Bear Medical Systems, Inc. · Mar 1989
BEAR NVM-1
K872660 · Bear Medical Systems, Inc. · Feb 1988