TEMPERATURE CONTROL & MONITOR— 510(k) K841402
Substantially EquivalentSams, Inc.
FDA 510(k) clearance K841402 for TEMPERATURE CONTROL & MONITOR, Substantially Equivalent on 1984-06-11. Applicant: Sams, Inc.. Device class: 2.
Clearance details
- Applicant
- Sams, Inc.
- Product code
- Code DWC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DWC
view allAdverse events under product code DWC
product code DWC- Death
- 124
- Injury
- 233
- Malfunction
- 3,727
- Total
- 4,084
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K841402
K-number listed on FDA's recall record- Z-1790-2021 — The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940
- Z-1417-2018 — Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
- Z-2208-2016 — Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM is indicated for controlling and monitoring patient temperature.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K841402.
Data sourced from openFDA. This site is unofficial and independent of the FDA.