Cleared Traditional

K945221 - SUTTER MODEL 6000 HAND CPM DEVICE (FDA 510(k) Clearance)

Class I Physical Medicine device.

K945221 · Sutter Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
124d
Days
Class 1
Risk

K945221 is an FDA 510(k) clearance for the SUTTER MODEL 6000 HAND CPM DEVICE. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Sutter Corp. (San Diego, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 124 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.

View all Sutter Corp. devices

Submission Details

510(k) Number K945221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1994
Decision Date February 27, 1995
Days to Decision 124 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 115d · This submission: 124d
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.