Q Core Medical , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Q Core Medical , Ltd.” (first 2013, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 284 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 |
|---|---|---|
| 2013 | 1 | 384 |
| 2014 | 2 | 114 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 284 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 412 |
| 2021 | 0 | — |
| 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 Q Core Medical , Ltd. took a median 348 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 4 | 4 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Q Core Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192860 | Sapphire Infusion Pump, Sapphire administration sets | FRN | 2020-11-19 | 412 |
| K161667 | Sapphire Infusion Pump | FRN | 2017-03-27 | 284 |
| K141389 | SAPPHIRE INFUSION PUMP | FRN | 2014-12-11 | 198 |
| K141834 | SAPPHIRE ADMINISTRATION SET | FPA | 2014-08-05 | 29 |
| K123049 | SAPPHIRE INFUSION PUMP | FRN | 2013-10-17 | 384 |
Recalls
openFDA lists no recalls under a recalling firm named Q Core Medical , Ltd..
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 Q Core Medical , Ltd. (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 are listed under Q Core Medical , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Q Core Medical , Ltd.” (first 2013, latest 2020), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Q Core Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Q Core Medical , Ltd. is 284 days.
Which FDA product codes appear under Q Core Medical , Ltd.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 4); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 5 Q Core Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Q Core Medical , Ltd.'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.