CurveBeam, LLC
Hatfield, PA, US
CurveBeam, LLC appears in FDA device records in Hatfield, PA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 6 510(k) clearances for CurveBeam, LLC between 2012 and 2024. The busiest year on record is 2018, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241713 | HiRise (1040-230) | JAK | Substantially Equivalent | |
| K203187 | HiRise | JAK | Substantially Equivalent | |
| K181962 | CubeVue | LLZ | Substantially Equivalent | |
| K180727 | LineUp | JAK | Substantially Equivalent | |
| K170789 | In Reach | JAK | Substantially Equivalent | |
| K113548 | PEDCAT | JAK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009543051 | 3009543051 | CurveBeam, LLC | 2800 Bronze Dr., Hatfield, PA 19440 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain