Cleared Traditional

IAB ANCHOR (K922103) - FDA 510(k) Clearance

Class I General Hospital device.

K922103 · Datascope Corp. · General Hospital
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Aug 1993
Decision
454d
Days
Class 1
Risk

K922103 is an FDA 510(k) clearance for the IAB ANCHOR. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on August 3, 1993 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Datascope Corp. devices

Submission Details

510(k) Number K922103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1992
Decision Date August 03, 1993
Days to Decision 454 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
325d slower than avg
Panel avg: 129d · This submission: 454d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.