Graseby Medical , Ltd.: FDA clearances and approvals
Graseby Medical , Ltd. has 5 FDA 510(k) clearances (first 1992, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time: 273 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 4 | 4 |
| MEA | Pump, Infusion, Pca | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Graseby Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944721 | 9000 INFUSION PUMP | FRN | 1995-08-11 | 322 |
| K931318 | 3400 INFUSION PUMP | FRN | 1994-12-09 | 633 |
| K915270 | PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 | MEA | 1992-08-24 | 273 |
| K912193 | 3000 INFUSION PUMP | FRN | 1992-02-14 | 273 |
| K912192 | 3100 INFUSION PUMP | FRN | 1992-02-14 | 273 |
Recalls
openFDA lists no recalls under a recalling firm named Graseby Medical , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Graseby Medical , Ltd.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Graseby Medical , Ltd. have?
Graseby Medical , Ltd. has 5 FDA 510(k) clearances (first 1992, latest 1995), across 2 product codes in 1 review panel.
How long does FDA take to clear Graseby Medical , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Graseby Medical , Ltd.'s cleared 510(k)s is 273 days.
What devices does Graseby Medical , Ltd. make?
Its most frequent FDA product codes are FRN (Pump, Infusion, 4); MEA (Pump, Infusion, Pca, 1).
Has Graseby Medical , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Graseby Medical , Ltd. Related entities may recall under other names.
Next steps
- See all 5 Graseby Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Graseby Medical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.