Cleared Traditional

INTERP-1000 (K921476) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 82
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