Cleared Traditional

K201404 - Passio Pump Drainage System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201404 · Bearpac Medical · Anesthesiology device
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Nov 2020
Decision
176d
Days
Class 2
Risk

K201404 is an FDA 510(k) clearance for the Passio Pump Drainage System. Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Bearpac Medical (Moultonborough, US). The FDA issued a Cleared decision on November 20, 2020 after a review of 176 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.5050 - 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 K201404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2020
Decision Date November 20, 2020
Days to Decision 176 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
37d slower than avg
Panel avg: 139d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWM Apparatus, Suction, Patient Care
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.