Cleared Traditional

SP 4 (K853541) - FDA 510(k) Clearance

K853541 · Robert Bosch Corp. · Physical Medicine device
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Mar 1986
Decision
214d
Days
-
Risk

K853541 is an FDA 510(k) clearance for the SP 4.

Submitted by Robert Bosch Corp. (St. James, US). The FDA issued a Cleared decision on March 28, 1986 after a review of 214 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. 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 Robert Bosch Corp. devices

Submission Details

510(k) Number K853541 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 26, 1985
Decision Date March 28, 1986
Days to Decision 214 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
99d slower than avg
Panel avg: 115d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -