Cleared Traditional

K864886 - RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL

K864886 is an FDA 510(k) clearance for RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL, manufactured by Nims/Respitrace Corp.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K864886 · Nims/Respitrace Corp. · Anesthesiology device
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Mar 1987
Decision
84d
Days
Class 2
Risk

K864886 is an FDA 510(k) clearance for the RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Nims/Respitrace Corp. (Washington, US). The FDA issued a Cleared decision on March 6, 1987 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K864886

510(k) Number K864886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1986
Decision Date March 06, 1987
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
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 41
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K864886.
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
RESPIRADYNE II(TM)
K863866 · Chesebrough-Pond'S U.S.A. Co. · Jan 1987
OHMEDA 5410 VOLUME MONITOR
K862687 · Ohmeda Medical · Sep 1986
OHMEDA 5420 VOLUME MONITOR
K862688 · Ohmeda Medical · Sep 1986
K864886 · RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL
Download PDF Nims/Respitrace Corp.