Cleared Traditional

K802112 - PA-1 LOW PRESSURE ALARM (FDA 510(k) Clearance)

K802112 · Puritan Bennett Corp. · Cardiovascular device
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Sep 1980
Decision
3d
Days
-
Risk

K802112 is an FDA 510(k) clearance for the PA-1 LOW PRESSURE ALARM.

Submitted by Puritan Bennett Corp. (Walker, US). The FDA issued a Cleared decision on September 6, 1980 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Puritan Bennett Corp. devices

Submission Details

510(k) Number K802112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1980
Decision Date September 06, 1980
Days to Decision 3 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 125d · This submission: 3d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -