Cleared Traditional

K823555 - MAGTARAK RESPIRATORY MONITOR & FLOW SENS

K823555 is an FDA 510(k) clearance for MAGTARAK RESPIRATORY MONITOR & FLOW SENS, manufactured by Penlon, Inc.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823555 · Penlon, Inc. · Anesthesiology device
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Jan 1983
Decision
35d
Days
Class 2
Risk

K823555 is an FDA 510(k) clearance for the MAGTARAK RESPIRATORY MONITOR & FLOW SENS. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Penlon, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 35 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 - K823555

510(k) Number K823555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1982
Decision Date January 05, 1983
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 61
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K823555.
POCKET SPIROMETER
K830995 · P.K. Morgan Instruments, Inc. · Apr 1983
RESPITRACE SYSTEM
K823782 · Respitrace Corp. · Mar 1983
COMPUTERIZED SPIROMETRY SYSTEM
K823922 · Ohio Medical Products · Feb 1983
BEAR VM-90 VENTILATION MONITOR
K822912 · Bear Medical Systems, Inc. · Nov 1982
SPIROX H
K812956 · Cairco , Ltd. · Jan 1982
SPIROX A
K812959 · Cairco , Ltd. · Jan 1982
K823555 · MAGTARAK RESPIRATORY MONITOR & FLOW SENS
Download PDF Penlon, Inc.