510(k) Report

FDA applicant

Cincinnati Sub-Zero Products, Inc.

Sharonville, OH12 decisions1991–201322 recalls

FDA records 12 decisions for Cincinnati Sub-Zero Products, Inc. (Sharonville, OH) from 1991 to 2013: 12 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and DWC (Controller, Temperature, Cardiopulmonary Bypass). Its devices cite 19 predicates, 8 of them its own earlier devices. 22 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cincinnati Sub-Zero Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 22010: 22011: 12012: 32013: 1
2007high 3 (2012) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2026

2009: 22010: 12011: 32013: 12014: 12016: 12017: 22018: 22019: 42021: 12026 (partial year): 3
2007high 4 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cincinnati Sub-Zero Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cincinnati Sub-Zero Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DWJSystem, Thermal Regulating9decisions
  • DWCController, Temperature, Cardiopulmonary Bypass1decision
  • BZTStethoscope, Esophageal, With Electrical Conductors1decision
  • FLLContinuous Measurement Thermometer1decision

Whose devices does it build on?

Its devices cite 19 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc. · 20103cite it
  • K942790Warm Air Hypertheermia System (Models #130 and #133)Cincinnati Sub-Zero Products, Inc. · 19952cite it
  • K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 20102cite it
  • K942599Warm Air Warming UnitCincinnati Sub-Zero Products, Inc. · 19952cite it
  • K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. · 20111cites it
  • K072621Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorCincinnati Sub-Zero Products, Inc. · 20071cites it

What has FDA decided for it lately?

  • K123946Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc. · 2013
  • K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc. · 20126 recalls
  • K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012
  • K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc. · 20121 recall
  • K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. · 20113 recalls
  • K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 20102 recalls
  • K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc. · 20106 recalls
  • K072621Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorCincinnati Sub-Zero Products, Inc. · 20071 recall

All 12 as Cincinnati Sub-Zero Products, Inc. →

What has been recalled?

22 recalls linked to its devices; the latest:

  • K110104Blanketrol II Model 222S; Thermal regulating system.Jul 13, 2026Class II
  • K101589Innercool Coolblue Console, Model STx; Thermal regulating system.Jul 13, 2026Class II
  • K101589Blanketrol III, Model 233; Thermal regulating system.Jul 13, 2026Class II
  • K122813Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used…Jun 17, 2021Class II
  • K101589CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product…Jul 2, 2019Class II
  • K101589Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management…Jul 2, 2019Class II

Other applicant names beginning “Cincinnati”

FDA records each applicant name separately; these may or may not be the same firm.

Cincinnati Sub-Zero 2Cincinnati Medical Technologies, Inc. 1