Cleared Traditional

K840276 - DISPOSABLE, PRESSURE RELIEF VALVE (FDA 510(k) Clearance)

K840276 · Hospitak, Inc. · Physical Medicine device
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Apr 1984
Decision
91d
Days
-
Risk

K840276 is an FDA 510(k) clearance for the DISPOSABLE, PRESSURE RELIEF VALVE.

Submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Hospitak, Inc. devices

Submission Details

510(k) Number K840276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date April 23, 1984
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -