OxyMinder Pro (10310)
FDA 510(k) K251245 · Bio-Med Device, Inc.
510(k) numberK251245
Submission
- Device name
- OxyMinder Pro (10310)
- Applicant
- Bio-Med Device, Inc.
Guilford, CT, US - Received
- April 22, 2025
- Decision date
- August 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1720
- Specialty
- Anesthesiology
Other 510(k)s with product code CCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | Salter Labs | 07/30/2026SE |
| K250002 | Smart Check O2 (MA0236)CCL · Traditional | Life Spark Medical, LLC | 04/24/2025SE |
| K221734 | Maxtec MaxO2 ME+pCCL · Traditional | Maxtec, LLC | 04/01/2023SE |
| K213933 | Percent Oxygen SensorsCCL · Traditional | Careox, LLC | 08/19/2022SE |
| K213948 | OxyMinderCCL · Traditional | Bio-Med Devices, Inc. | 03/17/2022SE |
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | Precision Medical, Inc. | 05/02/2018SE |
| K153659 | MaxO2MECCL · Traditional | Maxtec, LLC | 06/10/2016SE |
| K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesCCL · Traditional | GE Healthcare Finland Oy | 02/28/2013SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | Envitec-Wismar GmbH | 01/23/2013SE |
| K112402 | ULTRAMAXO2 Oxygen AnalyerCCL · Abbreviated | Maxtec, LLC | 12/14/2011SE |
Questions and answers
When was OxyMinder Pro (10310) cleared by the FDA?
OxyMinder Pro (10310) (K251245) received a 510(k) decision of Substantially Equivalent on August 11, 2025, 111 days after the submission was received.
What is the product code of K251245?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.