Cleared Traditional

PMD SYSTEM-20 (K883390) - FDA 510(k) Clearance

Class I General Hospital device.

K883390 · Datatek, Inc. · General Hospital
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Oct 1988
Decision
77d
Days
Class 1
Risk

K883390 is an FDA 510(k) clearance for the PMD SYSTEM-20. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Datatek, Inc. (Shreveport, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 77 days - a notably fast clearance cycle.

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: 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 Datatek, Inc. devices

Submission Details

510(k) Number K883390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date October 25, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
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.