Cleared Traditional

INFORMER PLUS (K943481) - FDA 510(k) Clearance

Class I General Hospital device.

K943481 · Micro-Tech Medical, Inc. · General Hospital
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Nov 1994
Decision
106d
Days
Class 1
Risk

K943481 is an FDA 510(k) clearance for the INFORMER PLUS. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Micro-Tech Medical, Inc. (East Hartford, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro-Tech Medical, Inc. devices

Submission Details

510(k) Number K943481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date November 02, 1994
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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.