Cleared Traditional

K961287 - ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM

K961287 is an FDA 510(k) clearance for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM, manufactured by Rocket Medical Plc. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K961287 · Rocket Medical Plc · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
114d
Days
Class 2
Risk

K961287 is an FDA 510(k) clearance for the ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on July 26, 1996 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Rocket Medical Plc devices

FDA 510(k) Submission Details - K961287

510(k) Number K961287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1996
Decision Date July 26, 1996
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDQ Device Classification - Class 2, Special Controls

Product Code KDQ Bottle, Collection, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - KDQ Bottle, Collection, Vacuum

All 33
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K961287.
OCEAN CHEST DRAIN
K043582 · Atrium Medical Corp. · Jan 2005
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
K984496 · Atrium Medical Corp. · May 1999
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
K962856 · Deknatel, Inc. · Aug 1996
MUCUS SPECIMEN TRAP
K962168 · Sage Products, Inc. · Jul 1996
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
K950677 · Atrium Medical Corp. · Apr 1995
PM9000 VAC TRAP
K941818 · Precision Medical, Inc. · Dec 1994