Oxicomplus
FDA 510(k) K911207 · Waters Instruments, Inc.
510(k) numberK911207
Submission
- Device name
- Oxicomplus
- Applicant
- Waters Instruments, Inc.
Rochester, MN, US - Received
- March 19, 1991
- Decision date
- August 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K053169 | RM3 Renal Preservation SystemKDK · Special | 01/17/2006SE |
| K042224 | RM3 Renal Preservation SystemKDN · Special | 10/22/2004SE |
| K971571 | RM3 Renal Preservation System--Control UnitKDN · Traditional | 07/29/1997SE |
| K921519 | OXICOM-2100DQA · Traditional | 10/23/1992SE |
| K863210 | VELCOM-100DPW · Traditional | 11/26/1986SE |
| K862161 | OSC-80 OximeterDQA · Traditional | 08/18/1986SE |
| K852909 | MVP - 6000BZC · Traditional | 11/14/1985SE |
| K834408 | TX-2 Thermal Dilution Cardiac OutputDXG · Traditional | 08/23/1984SE |
| K841876 | Polyurethane Thermal Dilution CathetDYG · Traditional | 07/13/1984SE |
| K813585 | Waters Ileostomy ValveKNT · Traditional | 04/09/1982SE |
Questions and answers
When was Oxicomplus cleared by the FDA?
Oxicomplus (K911207) received a 510(k) decision of Substantially Equivalent on August 26, 1991, 160 days after the submission was received.
What is the product code of K911207?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.