Cleared Traditional

BX-400S (K942195) - FDA 510(k) Clearance

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

K942195 · Bloomex International, Inc. · Physical Medicine device
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Aug 1995
Decision
489d
Days
Class 2
Risk

K942195 is an FDA 510(k) clearance for the BX-400S. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bloomex International, Inc. (Elmwood Park, US). The FDA issued a Cleared decision on August 14, 1995 after a review of 489 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Bloomex International, Inc. devices

Submission Details

510(k) Number K942195 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 12, 1994
Decision Date August 14, 1995
Days to Decision 489 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
374d slower than avg
Panel avg: 115d · This submission: 489d
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 K942195.
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
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HPM-6000
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SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046 · 3M Company · Jul 1985