Duramax Reusable Oximetry Sensor
FDA 510(k) K070408 · Nellcor Puritan Bennett, Inc.
510(k) numberK070408
Submission
- Device name
- Duramax Reusable Oximetry Sensor
- Applicant
- Nellcor Puritan Bennett, Inc.
Pleasanton, CA, US - Received
- February 12, 2007
- Decision date
- May 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code DQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional | Philips Medizin Systeme Böblingen GmbH | 05/29/2026SE |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 05/11/2026SE |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional | Philips Medizin Systeme | 05/01/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | Unimed Medical Supplies, Inc. | 04/14/2026SE |
| K252448 | AViTA Pulse Oximeter (SP61)DQA · Traditional | Avita Corporation | 02/27/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 02/17/2026SE |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional | Shenzhen Best Electronics Co., Ltd. | 01/07/2026SE |
| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
More from Unimed Medical Supplies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070899 | Puritan Bennett Legendair XL2CBK · Traditional | 12/13/2007SE |
| K060576 | Nellcor Oximax N-600X Pulse OximeterDQA · Traditional | 08/14/2006SE |
| K051271 | Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorDQA · Traditional | 01/10/2006SE |
| K052186 | Nellcor Oximax Pulse Oximetry Sensons (Max-A, Max-Al, Max-N, Max-I, Max-PDQA · Special | 11/10/2005SE |
| K051352 | Oximax NPB-40 Handheld Pulse OximeterDQA · Traditional | 08/11/2005SE |
| K050072 | Goodknight 425STBZD · Special | 06/13/2005SE |
| K033973 | Oxisensor II Recycled Sensor and Oximax Recycled SensorNLF · Traditional | 12/13/2004SE |
| K030787 | Shiley Flextra Tracheostomy TubeJOH · Traditional | 11/14/2003SE |
| K030930 | Oximax Softcare Sensors, Models Sc-A, Sc-Pr, Sc-Neo, Sc-NDQA · Traditional | 05/23/2003SE |
| K023494 | Nellcor Indgo Manual ResuscitatorBTM · Special | 02/07/2003SE |
Questions and answers
When was Duramax Reusable Oximetry Sensor cleared by the FDA?
Duramax Reusable Oximetry Sensor (K070408) received a 510(k) decision of Substantially Equivalent on May 25, 2007, 102 days after the submission was received.
What is the product code of K070408?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.