Cleared Traditional

THRUST-AIRE MODEL 2001 (K860618) - FDA 510(k) Clearance

K860618 · Charron Industries, Inc. · Physical Medicine device
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Apr 1986
Decision
50d
Days
-
Risk

K860618 is an FDA 510(k) clearance for the THRUST-AIRE MODEL 2001.

Submitted by Charron Industries, Inc. (Hartford, US). The FDA issued a Cleared decision on April 10, 1986 after a review of 50 days - a notably fast clearance 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: 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 Charron Industries, Inc. devices

Submission Details

510(k) Number K860618 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 19, 1986
Decision Date April 10, 1986
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -