Cleared Traditional

K230319 - Passio Pump Drainage System (FDA 510(k) Clearance)

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

K230319 · Bearpac Medical · Gastroenterology & Urology device
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Nov 2023
Decision
291d
Days
Class 2
Risk

K230319 is an FDA 510(k) clearance for the Passio Pump Drainage System. Classified as Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (product code PNG), Class II - Special Controls.

Submitted by Bearpac Medical (Moultonborough, US). The FDA issued a Cleared decision on November 24, 2023 after a review of 291 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K230319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 06, 2023
Decision Date November 24, 2023
Days to Decision 291 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 130d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
Definition For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling

All 14
Devices cleared under the same product code (PNG) and FDA review panel - the closest regulatory comparables to K230319.
ASEPT® Glide Peritoneal Drainage System
K241278 · Pfm Medical, Inc. · Jan 2025
PeritX™ 1L Drainage Kit (90-1010)
K241946 · Bard Peripheral Vascular, Inc. · Dec 2024
ASEPT Peritoneal Drainage System
K221779 · Pfm Medical, Inc. · May 2023
Aspira Peritoneal Drainage System
K212675 · Merit Medical Systems, Inc. · Dec 2021