Cleared Traditional

K163321 - Rocket Indwelling Pleural Catheter (IPC...

K163321 is an FDA 510(k) clearance for Rocket Indwelling Pleural Catheter (IPC..., manufactured by Rocket Medical Plc. The device is a Class 2 Anesthesiology device with product code DWM cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K163321 · Rocket Medical Plc · Anesthesiology device
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Aug 2017
Decision
265d
Days
Class 2
Risk

K163321 is an FDA 510(k) clearance for the Rocket Indwelling Pleural Catheter (IPC) Insertion Kit. Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Rocket Medical Plc (Washington, GB). The FDA issued a Cleared decision on August 17, 2017 after a review of 265 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.

View all Rocket Medical Plc devices

FDA 510(k) Submission Details - K163321

510(k) Number K163321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2016
Decision Date August 17, 2017
Days to Decision 265 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 140d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DWM Apparatus, Suction, Patient Care

All 10
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