Cleared Traditional

K863872 - TAMPER HAMPER (FDA 510(k) Clearance)

K863872 · Hydro-Med Products, Inc. · General Hospital
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Feb 1987
Decision
130d
Days
-
Risk

K863872 is an FDA 510(k) clearance for the TAMPER HAMPER. Classified as Container, Frozen Donor Tissue Storage (product code LPZ).

Submitted by Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General Hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Hydro-Med Products, Inc. devices

Submission Details

510(k) Number K863872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date February 10, 1987
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 128d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LPZ Container, Frozen Donor Tissue Storage
Device Class -