Cleared Traditional

K810271 - DIRECT CURRENT BONE GROWTH STIM. AN. PAD (FDA 510(k) Clearance)

K810271 · Andover Medical, Inc. · Toxicology device
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Feb 1981
Decision
17d
Days
-
Risk

K810271 is an FDA 510(k) clearance for the DIRECT CURRENT BONE GROWTH STIM. AN. PAD.

Submitted by Andover Medical, Inc. (Walker, US). The FDA issued a Cleared decision on February 19, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Toxicology 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 Andover Medical, Inc. devices

Submission Details

510(k) Number K810271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1981
Decision Date February 19, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 87d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -