Cleared Traditional

K972258 - HI-CARE CLOSED SUCTION SYSTEM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K972258 · Mallinckrodt Medical · Anesthesiology device
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Dec 1997
Decision
195d
Days
Class 1
Risk

K972258 is an FDA 510(k) clearance for the HI-CARE CLOSED SUCTION SYSTEM. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on December 29, 1997 after a review of 195 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K972258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1997
Decision Date December 29, 1997
Days to Decision 195 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 139d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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.