Cleared Traditional

K801254 - PENLON I.D.P. PRESSSURE FAILURE ALARM

K801254 is the FDA 510(k) clearance for PENLON I.D.P. PRESSSURE FAILURE ALARM by Penlon, Inc.. It is a Class 2 Anesthesiology device (product code CAP) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K801254 · Penlon, Inc. · Anesthesiology device
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Jun 1980
Decision
12d
Days
Class 2
Risk

K801254 is an FDA 510(k) clearance for the PENLON I.D.P. PRESSSURE FAILURE ALARM. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Penlon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 12 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K801254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1980
Decision Date June 09, 1980
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 140d · This submission: 12d
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 Anesthesiology devices follow this clearance model.