Cleared Traditional

AUTOMASTER (K904934) - FDA 510(k) Clearance

K904934 · Team Mfg., Inc. · Physical Medicine device
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May 1991
Decision
201d
Days
-
Risk

K904934 is an FDA 510(k) clearance for the AUTOMASTER.

Submitted by Team Mfg., Inc. (Augusta, US). The FDA issued a Cleared decision on May 21, 1991 after a review of 201 days - an extended review cycle.

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

View all Team Mfg., Inc. devices

Submission Details

510(k) Number K904934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1990
Decision Date May 21, 1991
Days to Decision 201 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 115d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IPQ
Device Class -