Cleared Traditional

K811114 - MODEL P-8 PROFESSIONAL

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

FDA 510(k) Submission Details - K811114

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 - Class ,

Product Code -
Device Class -