Accepted unranked evidence dossier
OMRON Evolv Wireless Upper Arm Blood Pressure Monitor
Exact model: BP7000 / HEM-7600T-Z · United States
Direct answer
The OMRON Evolv BP7000 has strong exact US regulatory identity and official manual documentation. Its peer-reviewed validation evidence carries a material family-level caveat because the paper and validation registry name HEM-7600T rather than the US BP7000/HEM-7600T-Z. Its score and category rank are therefore withheld while the deterministic scorer and comparison cohort are completed.
Product score
Withheld
No editor-assigned substitute
Category rank
Withheld
Comparison cohort incomplete
Evidence Confidence
Moderate
Separate from product score
Public Experience
Insufficient
No permitted review corpus used
Why score and rank are withheld
The production scorer and its tests are not yet validated. Exact applicability of HEM-7600T validation evidence to BP7000/HEM-7600T-Z remains a documented family-level caveat, and rank requires a sufficiently complete eligible category cohort.
Testing status: Public evidence only. MDRank has not performed hands-on or laboratory testing of this monitor.
Verified exact identity
- FDA K162092 names the Evolv model BP7000 and records product code DXN.
- AccessGUDID DI 00073796270001 identifies exact model BP7000 in US commercial distribution.
- The OMRON US manual places BP7000 and HEM-7600T-Z in the same specifications row.
- The validation paper and STRIDE BP entry name HEM-7600T, not BP7000 or HEM-7600T-Z; MDRank does not silently transfer exact-model validation status.
Regulatory and safety research
- FDA K162092 records a substantially equivalent decision dated November 22, 2016 for Evolv model BP7000.
- AccessGUDID exact DI 00073796270001 aligns BP7000 with K162092.
- Ten reviewed exact and alternate-name queries across openFDA enforcement and recall/correction datasets returned no indexed match.
- A no-match query is not proof that no differently named, lot-specific, future, non-US, or unindexed action exists.
- FDA clearance is not FDA approval, endorsement, independent validation, or proof of superior accuracy.
Clinical-validation evidence
- The peer-reviewed HEM-7600T study reports passing ANSI/AAMI/ISO 81060-2:2013 criteria in adults.
- The reviewed paper does not name BP7000 or HEM-7600T-Z.
- The HEM-7600T result is shown as family-level context, not exact BP7000 validation proof.
HSA/FSA eligibility
Eligible per a named exact third-party listing
HSA Shopping identifies the exact OMRON Evolv BP7000 listing as HSA/FSA eligible.
- • The source is third-party eligibility guidance, not a plan-administrator determination.
- • MDRank did not complete checkout, test a benefit card, or verify every linked seller and package.
- • Eligibility is displayed separately and does not affect the MDRank score or rank.
Manufacturer-attributed specifications
These specifications come from the cited manufacturer/FDA materials. MDRank did not independently measure them.
- Measurement method
- Oscillometric
- Integrated cuff range
- 22–42 cm (9–17 in)
- Display
- OLED
- Internal memory
- Up to 100 measurements; prior stored readings require transfer to a smart device for viewing
- Connectivity
- Bluetooth Low Energy with OMRON connect
- Power
- Four AAA batteries
- Manufacturer-stated pressure accuracy
- ±3 mmHg
- Manufacturer-stated pulse accuracy
- ±5% of displayed reading
- Integrated cuff replaceability
- FDA summary states the cuff is not replaceable
Persona Fit Matrix
Fit statements describe documented cuff and workflow requirements. They are not medical-suitability determinations.
| Persona | Fit | Confidence | Basis |
|---|---|---|---|
| Adult seeking a compact one-piece upper-arm format | Strong | High | Attached cuff, tubeless format, and documented 22–42 cm range. |
| Adult wanting app-based trend transfer | Strong | High | Bluetooth Low Energy and OMRON connect are documented. |
| Person avoiding smartphone use | Mixed | High | Current readings work without a phone, but historical readings cannot be reviewed on the monitor. |
| Household requiring separate on-device profiles | Poor or unverified | Moderate | No two-user mode was established in the reviewed official evidence. |
| Buyer prioritizing a replaceable cuff | Poor | High | The FDA summary states the integrated cuff is not replaceable. |
Material limitations
- • MDRank did not perform hands-on, laboratory, or independent performance testing.
- • Exact validation applicability remains unresolved between HEM-7600T and the US BP7000/HEM-7600T-Z.
- • The integrated cuff is not replaceable according to the FDA summary.
- • Prior stored readings require a compatible smart device; app behavior and compatibility can change.
- • Manufacturer portability, ease-of-use, movement-interference, and accuracy wording is not independent proof.
- • No licensed or API-permitted exact-model customer-review corpus was acquired.
- • No product photograph is used under MDRank's owner-approved no-product-media launch policy.
Evidence ledger
Evidence cutoff: July 21, 2026. Source class A is regulatory, government, registry, or peer-reviewed evidence; C is manufacturer documentation; D is current-offer or eligibility evidence.
Publication and change log
- • July 22, 2026: First human-approved public evidence dossier. Score, rank, public-experience claims, and product imagery withheld.
No product image, price, offer, affiliate link, rating schema, or editor-assigned score appears on this dossier.