Rocket Medical Plc: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Rocket Medical Plc” (first 1996, latest 2021), across 14 product codes in 7 review panels. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 126 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 158 |
| 2017 | 1 | 265 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 199 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rocket Medical Plc took a median 232 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWM | Apparatus, Suction, Patient Care | 3 | 3 |
| MQE | Needle, Assisted Reproduction | 2 | 2 |
| MQF | Catheter, Assisted Reproduction | 2 | 2 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| GXI | Probe, Radiofrequency Lesion | 1 | 1 |
| HEE | Set, Anesthesia, Paracervical | 1 | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
| ICX | Aniline | 1 | 1 |
Plus 4 more product codes.
Review panels
- Obstetrics and Gynecology (10)
- Anesthesiology (3)
- Gastroenterology and Urology (2)
- Cardiovascular (1)
- General Hospital (1)
- Neurology (1)
- Pathology (1)
Most recent Rocket Medical Plc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210509 | Rocket Platinum Cured Cathter | DWM | 2021-09-09 | 199 |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | DWM | 2017-08-17 | 265 |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | PNG | 2016-11-14 | 73 |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | PNG | 2016-03-29 | 244 |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | DWM | 2013-02-01 | 126 |
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | HEE | 2005-10-17 | 49 |
| K042264 | GUIDEWIRES | DQX | 2004-11-24 | 93 |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | HHK | 2004-10-04 | 250 |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | MQE | 2003-08-08 | 39 |
| K000340 | HYSTALOG HSG CATHETER | HES | 2000-04-19 | 76 |
9 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 2 recall events; 6 initiated in the last five years. Most recent: 2025-11-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Rocket Medical Plc (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Rocket of London, Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rocket Medical Plc?
FDA lists 19 510(k) clearances under the applicant name “Rocket Medical Plc” (first 1996, latest 2021), across 14 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rocket Medical Plc?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rocket Medical Plc is 89 days.
Which FDA product codes appear under Rocket Medical Plc?
The most frequent FDA product codes under this applicant name are DWM (Apparatus, Suction, Patient Care, 3); MQE (Needle, Assisted Reproduction, 2); MQF (Catheter, Assisted Reproduction, 2).
Next steps
- See all 19 Rocket Medical Plc clearances with predicates and recalls
- Run predicate analysis for product code DWM, Rocket Medical Plc's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.