Cleared Traditional

K163321 - Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (FDA 510(k) Clearance)

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

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

Submission Details

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
126d slower than avg
Panel avg: 139d · This submission: 265d
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.