Cleared Traditional

K910026 - ATI MEDICAL COMFORT PLUS CPM PAD

K910026 is an FDA 510(k) clearance for ATI MEDICAL COMFORT PLUS CPM PAD, manufactured by Ati Medical, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K910026 · Ati Medical, Inc. · Physical Medicine device
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Jan 1991
Decision
15d
Days
Class 1
Risk

K910026 is an FDA 510(k) clearance for the ATI MEDICAL COMFORT PLUS CPM PAD. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Ati Medical, Inc. (Las Vegas, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K910026

510(k) Number K910026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1991
Decision Date January 18, 1991
Days to Decision 15 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
101d faster than avg
Panel avg: 116d · This submission: 15d
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 158
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K910026.
ROMFLEX
K905718 · Paraflex Corp. · Feb 1991
DANNIFLEX MODEL 500TM CPM
K904735 · Buckman Co., Inc. · Jan 1991
ROMFLEX REHAB EQUIP EXTREMITIES UNIT
K910150 · Dyna Flex, Intl. · Jan 1991
ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT
K910149 · Dyna Flex, Intl. · Jan 1991
ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT
K910151 · Dyna Flex, Intl. · Jan 1991
ROMFLEX REHABILITATION EQUIPMENT
K905299 · Dyna Flex, Intl. · Dec 1990
K910026 · ATI MEDICAL COMFORT PLUS CPM PAD
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