Cleared Traditional

K850207 - PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL (FDA 510(k) Clearance)

K850207 · Syncor Intl. Corp. · Radiology device
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Mar 1985
Decision
42d
Days
-
Risk

K850207 is an FDA 510(k) clearance for the PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL.

Submitted by Syncor Intl. Corp. (Sylmar, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Radiology 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: 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 Syncor Intl. Corp. devices

Submission Details

510(k) Number K850207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1985
Decision Date March 01, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -