Altrix Precision Temperature Management System
510(k) K152266
Altrix Precision Temperature Management System is a Class II device made by Stryker Medical, cleared under FDA 510(k) K152266 on 2 Dec 2016, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152266 | Date2 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K152266
Recalls
-
- Terminated Z-0235-2019
Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter
Timeline
- Cleared FDA 510(k) K152266
- Recall initiated FDA recalls Z-0235-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DWJ
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5900
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K152266
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Altrix 8001-064-110 | 8001-064-110 / 8001-064-110 | 07613327175400 | — | No longer on the market |
| Altrix 8001-064-120 | 8001-064-120 / 8001-064-120 | 07613327175394 | — | No longer on the market |
| Altrix 8001-064-130 | 8001-064-130 / 8001-064-130 | 07613327175363 | — | No longer on the market |
| Altrix Temperature Management Hose 8003-002-007 | 8003-002-007 / 8003-002-007 | 07613327374186 | — | No longer on the market |
| Altrix Temperature Management Hose 8003-002-107 | 8003-002-107 / 8003-002-107 | 07613327369014 | — | No longer on the market |
| Insulated Clik Tite 8001-064-037 | 8001-064-037 / 8001-064-037 | 07613327175295 | — | No longer on the market |
| Insulated Clik-Tite 8001-064-035 | 8001-064-035 / 8001-064-035 | 07613327175301 | — | No longer on the market |
| Insulated Colder Connector 8001-064-135 | 8001-064-135 / 8001-064-135 | 07613327175325 | — | No longer on the market |
| Insulated Colder Connector 8001-064-137 | 8001-064-137 / 8001-064-137 | 07613327175349 | — | No longer on the market |
| Rapr Round 8001-061-630 | 8001-061-630 / 8001-061-630 | 07613327261349 | — | No longer on the market |
| Rapr Round 8001-061-640 | 8001-061-640 / 8001-061-640 | 07613327261387 | — | No longer on the market |
| Rapr Round 8001-061-650 | 8001-061-650 / 8001-061-650 | 07613327261394 | — | No longer on the market |
| Rapr Round 8001-061-660 | 8001-061-660 / 8001-061-660 | 07613327261400 | — | No longer on the market |
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