Data / Medical devices / United Kingdom / Rocket Medical Plc

Rocket Medical Plc: FDA-registered device maker in WASHINGTON Sunderland, United Kingdom, 9 510(k) clearances

Name: Rocket Medical Plc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Rocket Medical Plc is registered with the FDA (registration 9610632) in WASHINGTON Sunderland, United Kingdom. It lists 16 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 29, 2016. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9610632
FEI number: 3002808026
Address: Sedling Road, WASHINGTON Sunderland, United Kingdom, NE38 9BZ
Owner or operator: Rocket Medical Plc (8010022)
Roles: Manufacturer, Repackager or relabeler
First device listed: September 22, 1997
Registered through: 2026
Brand names listed: #K000205, #K000340, #K000394, #K844608, #K972867, #K980061, #K994327, Aspiration & Collection and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Assisted Reproduction	MQG	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Patient Care	DWM	2	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Manufacturer	accessdata.fda.gov
Cannula, Intrauterine Insemination	MFD	2	Manufacturer	accessdata.fda.gov
Catheter, Assisted Reproduction	MQF	2	Manufacturer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer	accessdata.fda.gov
Chest Drainage Kit	PAD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrode, Circular (Spiral), Scalp And Applicator	HGP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)	HES	2	Manufacturer	accessdata.fda.gov
Needle, Assisted Reproduction	MQE	2	Manufacturer	accessdata.fda.gov
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	PNG	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Tubing And Tubing/Filter Fits	NVT	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 29, 2016	K152105	Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set	PNG	Unknown	Rocket Medical Plc	accessdata.fda.gov
February 1, 2013	K123033	ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B	DWM	Substantially Equivalent	Rocket Medical Plc	accessdata.fda.gov
August 8, 2003	K032015	EMBRYON ULTRASOUND NEEDLE GUIDE	MQE	Substantially Equivalent	Rocket Medical Plc	accessdata.fda.gov
April 19, 2000	K000340	HYSTALOG HSG CATHETER	HES	Substantially Equivalent	Rocket Medical Plc	accessdata.fda.gov
April 19, 2000	K000205	EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES	MQE	Substantially Equivalent	Rocket Medical Plc	accessdata.fda.gov
February 29, 2000	K000394	CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT	MQG	Substantially Equivalent	Rocket Medical Plc	accessdata.fda.gov
February 28, 2000	K994327	EMBRYON TRANSFER CATHETERS/SETS	MQF	Substantially Equivalent	Rocket Medical Plc	accessdata.fda.gov
March 2, 1998	K980061	EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER	MFD	Substantially Equivalent	Rocket Medical Plc	accessdata.fda.gov
May 1, 1985	K844608	SURGICRAFT COPELAND DISPOSABLE	HGP	Substantially Equivalent	A.W. Showell (Surgicraft) , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 7, 2025	97994	Class II	Ongoing	Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indic	IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.	accessdata.fda.gov
August 1, 2019	83587	Class II	Terminated	Rocket KCH Fetal Bladder Drainage Catheter Model: R57405	A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.