Andon Blood Pressure Cuff
FDA 510(k) K133117 · Andon Health Co, Ltd.
510(k) numberK133117
Submission
- Device name
- Andon Blood Pressure Cuff
- Applicant
- Andon Health Co, Ltd.
Tianjin, CN - Received
- September 30, 2013
- Decision date
- March 4, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXQ – Blood Pressure Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1120
- Specialty
- Cardiovascular
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Other 510(k)s with product code DXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | Medline Industries, LP | 06/22/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | Nihon Kohden Corporation | 05/06/2026SE |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…DXQ · Traditional | Shenzhen Best Electronics Co., Ltd. | 02/13/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | Unimed Medical Supplies, Inc. | 01/09/2026SE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | Baxter Healthcare Corporation | 12/16/2025SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | Avita Corporation | 09/03/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | Unimed Medical Supplies, Inc. | 07/15/2025SE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuffDXQ · Traditional | Shenzhen Medke Technology Co., Ltd. | 10/31/2024SE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Longwan Medical Device Factory | 03/20/2024SE |
| K233276 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/21/2023SE |
More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
| 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 Andon Blood Pressure Cuff cleared by the FDA?
Andon Blood Pressure Cuff (K133117) received a 510(k) decision of Substantially Equivalent on March 4, 2014, 155 days after the submission was received.
What is the product code of K133117?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.