BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM— 510(k) K110104
Substantially EquivalentCincinnati Sub-Zero Products, Inc.
FDA 510(k) clearance K110104 for BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM, Substantially Equivalent on 2011-02-04. Applicant: Cincinnati Sub-Zero Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Cincinnati Sub-Zero Products, Inc.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sharonville, OH, US
Recent devices under product code DWJ
view allMore clearances from Cincinnati Sub-Zero Products, Inc.
view all- K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
- K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
- K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
- K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
- K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
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 K110104
K-number listed on FDA's recall record- Z-2968-2026 — Blanketrol II Model 222S; Thermal regulating system.
- Z-0418-2020 — Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
- Z-1679-2014 — 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110104.
Data sourced from openFDA. This site is unofficial and independent of the FDA.