Cleared Traditional

MBI-4 (K810247) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810247 · Bloomex International, Inc. · Physical Medicine device
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Mar 1981
Decision
40d
Days
Class 2
Risk

K810247 is an FDA 510(k) clearance for the MBI-4. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bloomex International, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1981 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Bloomex International, Inc. devices

Submission Details

510(k) Number K810247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1981
Decision Date March 10, 1981
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K810247.
NEUROMUSCULAR STIMULATOR 3105
K840467 · Medtronic Vascular · Feb 1984
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
K823279 · Medtronic Vascular · Nov 1982
RESPOND II...NEUROMUSCULAR STIMULATOR
K813008 · Medtronic Vascular · Dec 1981
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K803064 · Zimmer, Inc. · Dec 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · Medtronic Vascular · May 1980