Company
Securitas Healthcare LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (2 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IQA | System, Environmental Control, Powered | 10 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Securitas Healthcare LLC Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3 Open, Classified |
IQA | None listed |
| Jan 8, 2026 | Securitas Healthcare LLC Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3 Open, Classified |
IQA | None listed |
| Nov 27, 2024 | Securitas Healthcare LLC Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application Open, Classified |
IQA | None listed |
| Jul 23, 2024 | Securitas Healthcare LLC Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station. Open, Classified |
IQA | None listed |
| Jul 23, 2024 | Securitas Healthcare LLC Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response. Open, Classified |
IQA | None listed |
| May 31, 2024 | Securitas Healthcare LLC Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System. Open, Classified |
IQA | None listed |
| Nov 3, 2023 | Securitas Healthcare LLC Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm Open, Classified |
IQA | None listed |
| Nov 3, 2023 | Securitas Healthcare LLC Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm Open, Classified |
IQA | None listed |
| Nov 3, 2023 | Securitas Healthcare LLC Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm Open, Classified |
IQA | None listed |
| Mar 14, 2023 | Securitas Healthcare LLC Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system. Open, Classified |
IQA | None listed |