Ihealth Fingertip Pulse Oximeter
FDA 510(k) K131111 · Andon Health Co, Ltd.
510(k) numberK131111
Submission
- Device name
- Ihealth Fingertip Pulse Oximeter
- Applicant
- Andon Health Co, Ltd.
Tianjin, CN - Received
- April 19, 2013
- Decision date
- September 11, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless…DXN · Abbreviated | 08/04/2025SE |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional | 12/20/2024SE |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic…DXN · Abbreviated | 04/22/2024SE |
| K222869 | Arm Blood Pressure MonitorDXN · Abbreviated | 02/15/2023SE |
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)NUH · Abbreviated | 12/21/2022SE |
| K212598 | iHealth infrared Ear thermometer PT5FLL · Abbreviated | 01/28/2022SE |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure MonitorDXN · Abbreviated | 07/30/2021SE |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorDXN · Abbreviated | 07/29/2021SE |
| K202753 | iHealth Wireless No-Touch Forehead ThermometerFLL · Traditional | 03/08/2021SE |
| K202791 | iHealth Clinical Digital ThermometerFLL · Abbreviated | 01/05/2021SE |
Questions and answers
When was Ihealth Fingertip Pulse Oximeter cleared by the FDA?
Ihealth Fingertip Pulse Oximeter (K131111) received a 510(k) decision of Substantially Equivalent on September 11, 2013, 145 days after the submission was received.
What is the product code of K131111?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.