Accepted unranked evidence dossier

iHealth Track Blood Pressure Monitor

Exact model: KN-550BT · United States

Direct answer

The iHealth Track KN-550BT has a strong exact-model evidence packet: FDA clearance K160014, three commercial GUDID records, current standard and XL cuff packages, and a 2024 exact-model validation study that passed both reported criteria. Its numeric score and category rank remain withheld while MDRank completes and validates the deterministic scoring implementation.

Product score

Withheld

No editor-assigned substitute

Category rank

Withheld

Comparison cohort incomplete

Evidence Confidence

High

Separate from product score

Public Experience

Insufficient

No permitted review corpus used

Why score and rank are withheld

The category methodology is owner-approved, but the production scorer, normalized evidence adapter, fixtures, and commercial-isolation tests have not completed validation. Rank also requires a sufficiently complete eligible comparison cohort.

Testing status: Public evidence only. MDRank has not performed hands-on or laboratory testing of this monitor.

Verified exact identity

Exact US model KN-550BT appears across FDA clearance K160014, manufacturer support, exact-model validation, and three commercial GUDID records.
Primary DIs reviewed: 00850078377081, 00856362005005, and 00856362005395.
The current manufacturer offer separates standard SKU 550BT with a 22–42 cm cuff from SKU 550BT-XL with a 42–48 cm cuff.
No public official crosswalk was found mapping each of the three primary DIs to the standard versus XL retail package. The similarly named KN-550LT Track Pro is outside this dossier.

Regulatory and safety research

FDA K160014 identifies the Wireless Blood Pressure Monitor, model KN-550BT, and records a substantially equivalent decision dated July 13, 2016.
Three exact KN-550BT GUDID records identify an over-the-counter Class II noninvasive blood-pressure system in commercial distribution.
Fourteen exact-model, alias, identifier, and clearance queries across the reviewed 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

A 2024 peer-reviewed paper names the exact KN-550BT model.
The study reports 89 qualified participants and states that the device passed both reported AAMI/ESH/ISO criteria.
The reviewed PubMed packet did not establish funding independence; MDRank does not convert the study into a hands-on-testing claim.

HSA/FSA eligibility

Eligible per current exact-offer sources

The current manufacturer offer labels the Track standard and XL variants HSA/FSA eligible. HSA Shopping separately identifies the named iHealth Track offer as eligible.

• Eligibility is displayed separately and does not affect the MDRank score or rank.
• MDRank did not complete checkout or test benefit-card acceptance.
• Plan rules, documentation requirements, seller coding, and reimbursement can vary.

Manufacturer-attributed specifications

These specifications come from the cited manufacturer/FDA materials. MDRank did not independently measure them.

Measurement method: Oscillometric
Standard package cuff: 22–42 cm (8.66–16.5 in)
XL package cuff: 42–48 cm (16.5–18.9 in)
Display: Color-coded LCD
On-device memory: 60 readings per reviewed exact-model support specification
Connectivity: Bluetooth with iHealth MyVitals synchronization
Power: Four 1.5V AAA batteries
Manufacturer-stated pressure accuracy: ±3 mmHg
Manufacturer-stated pulse accuracy: ±5%

Persona Fit Matrix

Fit statements describe documented cuff and workflow requirements. They are not medical-suitability determinations.

Persona	Fit	Confidence	Basis
Adult arm circumference 22–42 cm	Strong with standard package	High	Current standard SKU cuff range.
Adult arm circumference 42–48 cm	Strong with XL package	High	Current XL SKU cuff range.
User wanting readings without routine app use	Strong	High	LCD and 60-reading on-device memory are documented; Bluetooth is used for synchronization.
Two-person household requiring separate on-device user banks	Weak or unresolved	Moderate	Reviewed exact sources document 60-reading memory but not separate two-user banks.
Arm circumference outside 22–48 cm	Not supported by reviewed packages	High	Current standard and XL package ranges together cover 22–48 cm.

Material limitations

• MDRank did not perform hands-on, laboratory, or independent performance testing.
• No official public crosswalk maps the three exact GUDID DIs to SKU 550BT versus 550BT-XL.
• The validation paper's funding independence was not established from the reviewed PubMed packet.
• The manufacturer support source exposes manual-derived specifications, but a current standalone exact manual PDF was not exposed through the reviewed support route.
• An older manufacturer correction identifies a KN-550BT/KN-550LT cover typo; no KN-550LT evidence is transferred here.
• 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.

Class AFDA K160014 record
Class AExact KN-550BT validation, PMID 37702596
Class CiHealth KN-550BT specifications and display symbols
Class CiHealth KN-550BT memory and synchronization support
Class CCurrent iHealth Track manufacturer offer
Class DHSA Shopping iHealth Track eligibility page
Class CiHealth privacy policy

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.