Cleared Traditional

K780981 - PORTABLE PNEUMATIC CALIBRATOR 65-150 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K780981 · Pennwalt Corp. · Anesthesiology device
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Aug 1978
Decision
49d
Days
Class 1
Risk

K780981 is an FDA 510(k) clearance for the PORTABLE PNEUMATIC CALIBRATOR 65-150. Classified as Calibrator, Pressure, Gas (product code BXX), Class I - General Controls.

Submitted by Pennwalt Corp. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1978 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2620 - 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 Pennwalt Corp. devices

Submission Details

510(k) Number K780981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1978
Decision Date August 02, 1978
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 139d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXX Calibrator, Pressure, Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2620
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.