Upper Arm Blood pressure monitor (BP7155D)— 510(k) K261929
Substantially EquivalentOMRON Healthcare, Inc.
FDA 510(k) clearance K261929 for Upper Arm Blood pressure monitor (BP7155D), Substantially Equivalent on 2026-09-10. Applicant: OMRON Healthcare, Inc.. Device class: 2.
Summary
The BP7155D is an upper arm blood pressure monitor from Omron, filed under DXN, non-invasive blood pressure measurement systems. Omron is the largest name in home blood pressure monitoring.
Class II, 21 CFR 870.1130, Cardiovascular panel. It's a Special 510(k), meaning Omron was modifying a monitor it already had cleared.
Omron Healthcare filed from Hoffman Estates, Illinois, its US headquarters. Review took 93 days (June 9 to September 10, 2026). That's long for a Special, though not by much.
Clearance details
- Applicant
- OMRON Healthcare, Inc.
- Product code
- Code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hoffman Estates, IL, US
Recent devices under product code DXN
view all- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
- K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
- K261061 — BP Go (BPP-855)
More clearances from OMRON Healthcare, Inc.
view all- DEN230076 — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)) +1 more
- K202228 — Omron Model BP7900 Blood Pressure Monitor + EKG
- K183215 — Focus TENS Therapy, Model PM710-M/-L
- K190693 — HEM-6410T-ZL Wrist Blood Pressure Monitor
- K182579 — Omron Model BP7900 Blood Pressure Monitor + EKG
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.