Cleared Traditional

K921476 - INTERP-1000

K921476 · Qmed, Inc. · Cardiovascular device
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Oct 1992
Decision
205d
Days
-
Risk

K921476 is an FDA 510(k) clearance for the INTERP-1000.

Submitted by Qmed, Inc. (Laurence Harbor, US). The FDA issued a Cleared decision on October 21, 1992 after a review of 205 days - an extended review cycle.

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

View all Qmed, Inc. devices

FDA 510(k) Submission Details - K921476

510(k) Number K921476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date October 21, 1992
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

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