Cincinnati Sub-Zero Products, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Cincinnati Sub-Zero Products, Inc.” (first 1991, latest 2013), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 100 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 37 |
| 2013 | 1 | 27 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 9 | 9 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (10)
- Anesthesiology (1)
- General Hospital (1)
Most recent Cincinnati Sub-Zero Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123946 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS | DWJ | 2013-01-17 | 27 |
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | DWC | 2012-12-18 | 96 |
| K121669 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) | DWJ | 2012-07-03 | 27 |
| K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS | DWJ | 2012-02-17 | 37 |
| K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM | DWJ | 2011-02-04 | 22 |
| K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS | DWJ | 2010-10-01 | 161 |
| K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS | DWJ | 2010-09-20 | 105 |
| K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR | BZT | 2007-12-13 | 87 |
| K070339 | DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES | FLL | 2007-09-26 | 233 |
| K942790 | WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) | DWJ | 1995-01-24 | 225 |
2 earlier clearances. See the full list in Caduvo.
Recalls
23 product recalls in 20 recall events; 0 initiated in the last five years. Most recent: 2017-11-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cincinnati Sub-Zero (2 510(k)s)
- Cincinnati Medical Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cincinnati Sub-Zero Products, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Cincinnati Sub-Zero Products, Inc.” (first 1991, latest 2013), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cincinnati Sub-Zero Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cincinnati Sub-Zero Products, Inc. is 100 days.
Which FDA product codes appear under Cincinnati Sub-Zero Products, Inc.?
The most frequent FDA product codes under this applicant name are DWJ (System, Thermal Regulating, 9); BZT (Stethoscope, Esophageal, With Electrical Conductors, 1); DWC (Controller, Temperature, Cardiopulmonary Bypass, 1).
Next steps
- See all 12 Cincinnati Sub-Zero Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Cincinnati Sub-Zero Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.