Cleared Traditional

ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B (K123033) - FDA 510(k) Clearance

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

K123033 · Rocket Medical Plc · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
126d
Days
Class 2
Risk

K123033 is an FDA 510(k) clearance for the ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING.... Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on February 1, 2013 after a review of 126 days - within the typical 510(k) review window.

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 K123033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date February 01, 2013
Days to Decision 126 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
14d faster than avg
Panel avg: 140d · This submission: 126d
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.

Regulatory Peers - DWM Apparatus, Suction, Patient Care

Devices cleared under the same product code (DWM) and FDA review panel - the closest regulatory comparables to K123033.
Rocket Platinum Cured Cathter
K210509 · Rocket Medical Plc · Sep 2021
Passio Pump Drainage System
K201404 · Bearpac Medical · Nov 2020
Passio Pump Drainage System
K190292 · Bearpac Medical · Jul 2019
ASPIRA PLEURAL DRAINAGE SYSTEM
K110409 · C.R. Bard, Inc. · May 2011
WILLIAM HARVEY VENTED MEDIASTINAL DRAIN
K803037 · C.R. Bard, Inc. · Feb 1981