Accu-Trac
FDA 510(k) K843055 · Olympic Medical Corp.
510(k) numberK843055
Submission
- Device name
- Accu-Trac
- Applicant
- Olympic Medical Corp.
Mchenry, IL, US - Received
- August 3, 1984
- Decision date
- May 28, 1985
- 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 |
|---|---|---|
| K081094 | Olympic Pasteurmatic, Models 3000 and 3500MEC · Special | 06/20/2008SE |
| K031149 | Olympic CFM 6000OMA · Special | 05/14/2003SE |
| K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330OMC · Traditional | 06/18/2002SE |
| K001056 | Olympic Warm-UpILY · Traditional | 09/29/2000SE |
| K983229 | Olympic Medical Lectromed Cerebral Function Monitor SystemOMA · Traditional | 03/23/1999SE |
| K971601 | Olympic Bili-BassinetLBI · Traditional | 09/24/1997SE |
| K972193 | Olympix Mini-Pasteurmatic (58210)LDS · Traditional | 09/05/1997SE |
| K971117 | WarmetteLHC · Traditional | 08/22/1997SE |
| K955357 | Olympic Smart Scale Model 50/50RAFRW · Traditional | 01/30/1996SE |
| K954434 | Olympic Infant ThermometerFLL · Traditional | 12/20/1995SE |
Questions and answers
When was Accu-Trac cleared by the FDA?
Accu-Trac (K843055) received a 510(k) decision of Substantially Equivalent on May 28, 1985, 298 days after the submission was received.
What is the product code of K843055?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.