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.
Class II, 21 CFR 870.1130. The Cardiovascular panel reviewed it as a Special 510(k).
Omron Healthcare filed from Hoffman Estates, Illinois. Review took 93 days (June 9 to September 10, 2026).
Clearance details
- Applicant
- OMRON Healthcare, Inc.
- Product code
- Product 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
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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.