Cleared Traditional

K830995 - POCKET SPIROMETER

K830995 is an FDA 510(k) clearance for POCKET SPIROMETER, manufactured by P.K. Morgan Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K830995 · P.K. Morgan Instruments, Inc. · Anesthesiology device
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Apr 1983
Decision
30d
Days
Class 2
Risk

K830995 is an FDA 510(k) clearance for the POCKET SPIROMETER. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by P.K. Morgan Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983 after a review of 30 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.

View all P.K. Morgan Instruments, Inc. devices

FDA 510(k) Submission Details - K830995

510(k) Number K830995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date April 28, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
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 35
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K830995.
MEDISHIELD PVM RESPIROMETER
K840453 · Ohio Medical Products · Mar 1984
PORTABLE MONITORING & SCREENING SPIROM.
K822689 · Boehringer Laboratories · Jul 1983
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
RMS 111F RESPIRATORY MONITORING SYSTEM
K800086 · The Perkin-Elmer Corp. · May 1980