# K120081: Norm-O-Temp Hyperthermia System Incliding Blankets/Pads

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Feb 17, 2012 after 37 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003349 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881322: Mini-Temp (TM), Seabrook Medical Systems, Inc. (1988). Our reading of the summary gave K881332, FDA’s number for Diaflex Grasp Forceps/Retrieval Loop & Cyto Brush (Baxter Healthcare Corp). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Seabrook Medical Systems Mini-Temp Hyperthermia system including…”.
- K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems, Cincinnati Sub-Zero Products, Inc. (2010)
- K011907: Snuggle Warm 4000 Convective Warming System, Sims Level 1, Inc. (2001)

## Recalls of this device
- Jun 20, 2019 · Class II · Z-2355-2019: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

## Indications for use
The Norm-O-Temp® Model 11I1Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The Norm-O-Temp system is composed of a heater, circulating pump, and blankets/pads. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Source page: https://510kreport.com/device/K120081
Methodology: https://510kreport.com/methodology