Rocket Medical
East Pembroke, MA, US
ROCKET MEDICAL appears in FDA device records in East Pembroke, MA. FDA records list 19 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Rocket Medical between 1996 and 2021. The busiest year on record is 2000, with 6. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 2000 | 6 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2013 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210509 | Rocket Platinum Cured Cathter | DWM | Unknown | |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | DWM | Substantially Equivalent | |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | PNG | Unknown | |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | PNG | Unknown | |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | DWM | Substantially Equivalent | |
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | HEE | Substantially Equivalent | |
| K042264 | GUIDEWIRES | DQX | Substantially Equivalent | |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | HHK | Substantially Equivalent | |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | MQE | Substantially Equivalent | |
| K000340 | HYSTALOG HSG CATHETER | HES | Substantially Equivalent | |
| K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES | MQE | Substantially Equivalent | |
| K994344 | NEUROTHERM RF CANNULA | GXI | Substantially Equivalent | |
| K000656 | EMBRYON GIFT TRANSFER CATHETERS/SETS | MQF | Substantially Equivalent | |
| K000394 | CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT | MQG | Substantially Equivalent | |
| K994327 | EMBRYON TRANSFER CATHETERS/SETS | MQF | Substantially Equivalent | |
| K980061 | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER | MFD | Substantially Equivalent | |
| K972856 | ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS | KNF | Substantially Equivalent | |
| K972867 | CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT | ICX | Substantially Equivalent | |
| K961287 | ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM | KDQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004056053 | 3004056053 | ROCKET MEDICAL | 50 Corporate Park Drive #890, East Pembroke, MA 02359 US | 2026 | No device listings on this registration |
| 9610632 | 3002808026 | ROCKET MEDICAL PLC | Sedling Road, WASHINGTON Sunderland NE38 9BZ GB | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MQGAccessory, Assisted Reproduction
- ICXAniline
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- DWMApparatus, Suction, Patient Care
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KDQBottle, Collection, Vacuum
- FCYBulb, Inflation, For Endoscope
- MFDCannula, Intrauterine Insemination
- MQFCatheter, Assisted Reproduction
- GBXCatheter, Irrigation
- PADChest Drainage Kit
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- HHKCurette, Suction, Endometrial (And Accessories)
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- MQENeedle, Assisted Reproduction
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- GXIProbe, Radiofrequency Lesion
- HEESet, Anesthesia, Paracervical
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- NVTTubing And Tubing/Filter Fits
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0955-2026 | Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. | Class II | Open, Classified | |
| Z-0954-2026 | Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. | Class II | Open, Classified | |
| Z-0953-2026 | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. | Class II | Open, Classified | |
| Z-0952-2026 | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. | Class II | Open, Classified | |
| Z-0951-2026 | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. | Class II | Open, Classified | |
| Z-0950-2026 | 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 indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. | Class II | Open, Classified | |
| Z-0512-2020 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain