Cleared Traditional

PM-PAGER (K933552) - FDA 510(k) Clearance

Class I General Hospital device.

K933552 · Hill Engineering · General Hospital
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Sep 1994
Decision
428d
Days
Class 1
Risk

K933552 is an FDA 510(k) clearance for the PM-PAGER. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Hill Engineering (Boxford, US). The FDA issued a Cleared decision on September 22, 1994 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2400 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

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Submission Details

510(k) Number K933552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1993
Decision Date September 22, 1994
Days to Decision 428 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
299d slower than avg
Panel avg: 129d · This submission: 428d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMI Monitor, Bed Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2400
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.