Cleared Traditional

K850910 - HUNTLEIGH FLOWTRON AIR, AC400/2 AIR (FDA 510(k) Clearance)

K850910 · Huntleigh Technology, Inc. · General & Plastic Surgery device
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Aug 1985
Decision
168d
Days
-
Risk

K850910 is an FDA 510(k) clearance for the HUNTLEIGH FLOWTRON AIR, AC400/2 AIR.

Submitted by Huntleigh Technology, Inc. (Aberdeen, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Huntleigh Technology, Inc. devices

Submission Details

510(k) Number K850910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date August 20, 1985
Days to Decision 168 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
54d slower than avg
Panel avg: 114d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -