Non-Stetho 7, UM-15TP
FDA 510(k) K821989 · Hirata Sangyo Co. USA, Inc.
510(k) numberK821989
Submission
- Device name
- Non-Stetho 7, UM-15TP
- Applicant
- Hirata Sangyo Co. USA, Inc.
Mchenry, IL, US - Received
- July 7, 1982
- Decision date
- October 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
More from 80 Beats Medical GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K864106 | Sr-Model 230 (Modification)FRN · Traditional | 11/19/1986SE |
| K842289 | Sr- Model 230FRN · Traditional | 07/25/1984SE |
| K833542 | Surgical InstrumentGEN · Traditional | 11/28/1983SE |
| K833541 | Surgical InstrumentGAD · Traditional | 11/28/1983SE |
| K832686 | Multiple Manual Surgical InstrumentsHTO · Traditional | 10/14/1983SE |
| K831583 | GP-303DXN · Traditional | 07/19/1983SE |
| K822571 | Syringe PumpFRN · Traditional | 10/08/1982SE |
Questions and answers
When was Non-Stetho 7, UM-15TP cleared by the FDA?
Non-Stetho 7, UM-15TP (K821989) received a 510(k) decision of Substantially Equivalent on October 18, 1982, 103 days after the submission was received.
What is the product code of K821989?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.