Cleared Traditional

K854354 - THE BLEDSOE PASSIVE MOTION EXERCISER

K854354 is an FDA 510(k) clearance for THE BLEDSOE PASSIVE MOTION EXERCISER, manufactured by Medical Technology and Innovations, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K854354 · Medical Technology and Innovations, Inc. · Physical Medicine device
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Feb 1986
Decision
100d
Days
Class 1
Risk

K854354 is an FDA 510(k) clearance for the THE BLEDSOE PASSIVE MOTION EXERCISER. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Medical Technology and Innovations, Inc. (Grand Prairie, US). The FDA issued a Cleared decision on February 6, 1986 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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: 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.

FDA 510(k) Submission Details - K854354

510(k) Number K854354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date February 06, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 116d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BXB Exerciser, Powered

All 159
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K854354.
DANNIFLEX 400SL
K862730 · Danninger Medical Technology, Inc. · Jul 1986
GINGERBREAD MAN (TM)
K862093 · Southern Pride Manufacturing, Inc. · Jul 1986
HIP CONTINUOUS PASSIVE MOTION MACHINE
K862314 · Richards Medical Co., Inc. · Jul 1986
KNEE MACHINE
K852977 · Kaiser Medical · Oct 1985
TOTAL CPM
K852399 · Invacare Corp. · Aug 1985
PRESTON LOWER LIMB CPM UNIT
K852065 · Therapeutic Equipment Corp. · Jul 1985
K854354 · THE BLEDSOE PASSIVE MOTION EXERCISER
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