Cleared Traditional

K162457 - Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (FDA 510(k) Clearance)

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

K162457 · Rocket Medical Plc · Gastroenterology & Urology device
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Nov 2016
Decision
73d
Days
Class 2
Risk

K162457 is an FDA 510(k) clearance for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. Classified as Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (product code PNG), Class II - Special Controls.

Submitted by Rocket Medical Plc (Washington, GB). The FDA issued a Cleared decision on November 14, 2016 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rocket Medical Plc devices

Submission Details

510(k) Number K162457 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 02, 2016
Decision Date November 14, 2016
Days to Decision 73 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 130d · This submission: 73d
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 K162457.
ASEPT® Glide Peritoneal Drainage System
K241278 · Pfm Medical, Inc. · Jan 2025
PeritX™ 1L Drainage Kit (90-1010)
K241946 · Bard Peripheral Vascular, Inc. · Dec 2024
Passio Pump Drainage System
K230319 · Bearpac Medical · Nov 2023
ASEPT Peritoneal Drainage System
K221779 · Pfm Medical, Inc. · May 2023
Aspira Peritoneal Drainage System
K212675 · Merit Medical Systems, Inc. · Dec 2021