Cleared Traditional

K822755 - LATEX PENROSE TUBING (FDA 510(k) Clearance)

K822755 · American Hospital Supply Corp. · General & Plastic Surgery device
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Jan 1983
Decision
135d
Days
-
Risk

K822755 is an FDA 510(k) clearance for the LATEX PENROSE TUBING.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 135 days - within the typical 510(k) review window.

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 American Hospital Supply Corp. devices

Submission Details

510(k) Number K822755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1982
Decision Date January 21, 1983
Days to Decision 135 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
21d slower than avg
Panel avg: 114d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -