510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K961287Substantially Equivalent

Rocket Pleuraseal II Chest Drainage System

Rocket Medical, Washington, Tyne & Wear, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961287 is the FDA 510(k) clearance record for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM, a class II device, cleared for Rocket Medical Plc on under FDA product code KDQ (Bottle, Collection, Vacuum). FDA records list 19 510(k) clearances for Rocket Medical Plc, from to . As of , FDA records show no recalls naming K961287.

Clearance record

Decision date
Received
(114 days to decision)
Product code
KDQ Bottle, Collection, Vacuum
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Rocket Medical Plc Factories 3 & 4,, Washington, Tyne & Wear, GB
510(k) summary
Summary
Third party review
No

Clearances, product code KDQ

Trailing 12 months

FDA records hold no clearances under product code KDQ in the trailing twelve months.

FDA records show no clearances under product code KDQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260