Cleared Traditional

K902381 - PENLON BREATHING SYSTEM PRESSURE MONITOR

K902381 is the FDA 510(k) clearance for PENLON BREATHING SYSTEM PRESSURE MONITOR by Penlon, Inc.. It is a Class 2 Toxicology device (product code CAP) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K902381 · Penlon, Inc. · Toxicology device
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Aug 1990
Decision
79d
Days
Class 2
Risk

K902381 is an FDA 510(k) clearance for the PENLON BREATHING SYSTEM PRESSURE MONITOR. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Penlon, Inc. (Newtown, US). The FDA issued a Cleared decision on August 17, 1990 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 868.2600 - the FDA toxicology 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 Penlon, Inc. devices

Submission Details

510(k) Number K902381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date August 17, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 87d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 Toxicology devices follow this clearance model.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 14
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K902381.
DISPOSABLE PRESSURE MANOMETER
K022402 · Vital Signs, Inc. · Aug 2002
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990
OHMEDA 5500 AIRWAY PRESSURE MONITOR
K864536 · Ohmeda Medical · Jan 1987
MODIFIED BAROMED BREATHING PRESSURE MONITOR
K861720 · Draeger Medical, Inc. · May 1986
DRAGER BAROMED
K840279 · Draeger Medical, Inc. · Mar 1984