Cleared Traditional

K870887 - WARD'S BREAST MEASURING DEVICE (FDA 510(k) Clearance)

K870887 · Downs Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
26d
Days
-
Risk

K870887 is an FDA 510(k) clearance for the WARD'S BREAST MEASURING DEVICE.

Submitted by Downs Surgical , Ltd. (Mitcham Surrey, GB). The FDA issued a Cleared decision on March 31, 1987 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K870887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1987
Decision Date March 31, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 114d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -