Contact Us →Public regulatory records
A manufacturing partner of Penacta holds two US FDA 510(k) clearances for pen injector devices. The records are public, and you can check them yourself before you contact us.
Direct answer
Two pen injector devices are the subject of US FDA 510(k) clearances granted in 2024: a pen injector (K240774) and a disposable pen injector assembly (K240961). Both were cleared as substantially equivalent under product code FMF, regulation 21 CFR 880.5860, Class II. Both records belong to a manufacturing partner of Penacta, not to Penacta. The records are public, and the holder identity is withheld here at the partner's request.
| Record field | K240774 | K240961 |
|---|---|---|
| 510(k) number | K240774 | K240961 |
| Device name on the record | Pen Injector | Disposable Pen Injector Assembly |
| Holder | Held by the manufacturing partner, not by Penacta. Holder identity is withheld at the partner's request. | |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Decision date | 2024-06-18 | 2024-08-15 |
| Product code | FMF — Syringe, Piston | FMF — Syringe, Piston |
| Regulation | 21 CFR 880.5860, Class II | 21 CFR 880.5860, Class II |
| Review panel | General Hospital | General Hospital |
The manufacturing partner asks not to be named publicly while we are still building the relationship, so this page gives the clearance numbers and the record fields but not the holder name. The FDA record itself is open: searching either number in the 510(k) database shows the full record, including the holder. We would rather tell you that plainly than present a redacted document and call it evidence.
Both records can be read in the FDA 510(k) database in under a minute, without contacting us. Search the database for the 510(k) number, or open the record directly:
We do not ask you to take this on trust. If a supplier cannot give you a registration number you can look up, that is the answer to that part of your evaluation.
| It does cover | It does not cover | |
|---|---|---|
| The device | The named device and the intended use described in that clearance, for the manufacturer named on the record. | A different configuration, a different manufacturer, or a device the record does not describe. |
| Your drug combination | Nothing about your drug. A 510(k) is a device clearance. | Compatibility with your formulation, or your drug–device combination product. |
| Your market | US marketing clearance for that device. | European, UK, Canadian or any other national approval. Those are separate, and we list the certifications that exist separately. |
| Commercial use | Evidence you can cite during supplier qualification. | Permission to describe a device as cleared when the configuration you order is not the cleared one. |
The same manufacturer publishes China CDE registration numbers for four device families. We pass them on as stated, and they can be checked on the CDE platform: internal-rotation pen injector B20250000677; self-locking 100-unit pen injector B20250000311; prefilled auto-injector, three-step, B20250000729.
These records stand on their own as public evidence about that manufacturer. Applicability to any Penacta project or catalogue configuration must be established through configuration-specific documentation; this page does not claim that applicability.