Cleared Traditional

K871012 - CONTINUOUS PASSIVE MOTION PATIENT KIT O...

K871012 is the FDA 510(k) clearance for CONTINUOUS PASSIVE MOTION PATIENT KIT O... by Cropper Medical, Inc.. It is a Class 1 Physical Medicine device (product code BXB) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K871012 · Cropper Medical, Inc. · Physical Medicine device
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Mar 1987
Decision
12d
Days
Class 1
Risk

K871012 is an FDA 510(k) clearance for the CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Cropper Medical, Inc. (Ashland, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 12 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.

View all Cropper Medical, Inc. devices

Submission Details

510(k) Number K871012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1987
Decision Date March 25, 1987
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 31
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K871012.
ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400
K872586 · Invacare Corp. · Sep 1987
MOTORIZED TREADMILL MODEL #FT2200
K872638 · Invacare Corp. · Sep 1987
DELUXE MOTORIZED TREADMILL MODEL #FT2300
K872639 · Invacare Corp. · Sep 1987
DANNIFLEX 400I
K870510 · Buckman Co., Inc. · Feb 1987
KNEECPM
K864427 · Invacare Corp. · Dec 1986
HIP CONTINUOUS PASSIVE MOTION MACHINE
K862314 · Richards Medical Co., Inc. · Jul 1986