Sensormedics Oxyshuttle Ii(Tm)
FDA 510(k) K913790 · Sensor Medics Corp.
510(k) numberK913790
Submission
- Device name
- Sensormedics Oxyshuttle Ii(Tm)
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- August 23, 1991
- Decision date
- February 26, 1992
- 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
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|---|---|---|---|
| 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 |
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| K032516 | HIOX80 Aerosol AdapterCAF · Traditional | 03/04/2004SE |
| K031745 | Infant Flow Plus Infant CPAP System with Sipap FunctionBZD · Traditional | 02/13/2004SE |
| K031883 | Lyra Nasal MaskBZD · Traditional | 08/25/2003SE |
| K030943 | Modification to HioxCBP · Traditional | 04/22/2003SE |
| K022192 | Pegasus Nasal CPAP SystemBZD · Traditional | 01/24/2003SE |
| K020665 | Hi-OxCBP · Traditional | 07/30/2002SE |
| K012085 | Somno Star & Series Sleep SystemOLV · Special | 08/02/2001SE |
| K012034 | Modification to: Sipap Infant Nasal CPAP CircuitBZD · Special | 07/24/2001SE |
| K991972 | Infant Flow SystemBZD · Special | 08/13/1999SE |
| K984254 | Infant Flow Ncpap MasksBZD · Traditional | 02/24/1999SE |
Questions and answers
When was Sensormedics Oxyshuttle Ii(Tm) cleared by the FDA?
Sensormedics Oxyshuttle Ii(Tm) (K913790) received a 510(k) decision of Substantially Equivalent on February 26, 1992, 187 days after the submission was received.
What is the product code of K913790?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.