Cleared Traditional

K800086 - RMS 111F RESPIRATORY MONITORING SYSTEM

K800086 is an FDA 510(k) clearance for RMS 111F RESPIRATORY MONITORING SYSTEM, manufactured by The Perkin-Elmer Corp.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K800086 · The Perkin-Elmer Corp. · Anesthesiology device
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May 1980
Decision
115d
Days
Class 2
Risk

K800086 is an FDA 510(k) clearance for the RMS 111F RESPIRATORY MONITORING SYSTEM. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 115 days - within the typical 510(k) review window.

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 The Perkin-Elmer Corp. devices

FDA 510(k) Submission Details - K800086

510(k) Number K800086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1980
Decision Date May 08, 1980
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 140d · This submission: 115d
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 27
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K800086.
SPIROMED RESPIROMETER
K831237 · Draeger Medical, Inc. · May 1983
COMPUTERIZED SPIROMETRY SYSTEM
K823922 · Ohio Medical Products · Feb 1983
BEAR VM-90 VENTILATION MONITOR
K822912 · Bear Medical Systems, Inc. · Nov 1982
SPIROMETER, MINI POSITIVE
K782145 · Boehringer Laboratories · Jan 1979
SPIROMETER, MONITORING W/ALARM
K780064 · Ohio Medical Products · Jan 1978
SPIROMETEO EXHAUST
K770907 · Timeter Instrument Corp. · Jul 1977