Cleared Traditional

Rocket Platinum Cured Cathter (K210509) - FDA 510(k) Clearance

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

K210509 · Rocket Medical Plc · Gastroenterology & Urology device
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Sep 2021
Decision
199d
Days
Class 2
Risk

K210509 is an FDA 510(k) clearance for the Rocket Platinum Cured Cathter. 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 September 9, 2021 after a review of 199 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.5050 - 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.

View all Rocket Medical Plc devices

Submission Details

510(k) Number K210509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 22, 2021
Decision Date September 09, 2021
Days to Decision 199 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 130d · This submission: 199d
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 Gastroenterology & Urology 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 K210509.
Aspira Pleural Drainage System
K212696 · Merit Medical Systems, Inc. · Mar 2023
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