Cleared Traditional

K811114 - MODEL P-8 PROFESSIONAL (FDA 510(k) Clearance)

K811114 · Bloomex International, Inc. · Physical Medicine device
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Nov 1981
Decision
214d
Days
-
Risk

K811114 is an FDA 510(k) clearance for the MODEL P-8 PROFESSIONAL.

Submitted by Bloomex International, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 23, 1981 after a review of 214 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 Bloomex International, Inc. devices

Submission Details

510(k) Number K811114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1981
Decision Date November 23, 1981
Days to Decision 214 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
99d slower than avg
Panel avg: 115d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -