510(k) · Cleared
ClearedEcho-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neko Health AB · QOK Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
Cleared on Sep 22, 2026 as substantially equivalent to DEN200038 (Continuse Biometrics, Ltd., 2021) after a 267-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Sep 22, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- QOK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200038 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200038 Gili Pro BioSensor (also known as “Gili BioSensor System”)Continuse Biometrics, Ltd. · 2021
- This deviceK254240 Echo-2Neko Health AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200038 | Gili Pro BioSensor (also known as “Gili BioSensor System”) | Continuse Biometrics, Ltd. | 2021 | — |
| 0 (this device) | K254240 | Echo-2 | Neko Health AB | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QOK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200038 | Gili Pro BioSensor (also known as “Gili BioSensor System”)Summary page 6…Legally Marketed Predicate/Reference Devices 1.3.1 Gili Pro Biosensor The primary predicate device for the Echo-2 is the Gili Pro Biosensor cleared under DEN200038. Submission Number DEN200038 Trade Name: Gili Pro Biosensor Common Name:… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QOK devicesQOK Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QOK
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QOK
Too few QOK 510(k)s in any year since 2007 to give a median.
Recalls per year · QOK
No recall names QOK since 2007.
Adverse event reports per year · QOK
No MAUDE report names QOK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Echo-2 device includes an optical module that is intended to capture motion-vibration signals from a illuminated skin surface for assessment of physiological information. Such information, captured during spot-measurement, includes: Heart rate. The Echo-2 device is indicated for use by or under the supervision of healthcare professionals for adult patients in a professional healthcare setting. The Echo-2 device should be used with an individual in a…
Read the full statement (118 words)
The Echo-2 device includes an optical module that is intended to capture motion-vibration signals from a
illuminated skin surface for assessment of physiological information. Such information, captured during
spot-measurement, includes: Heart rate.
The Echo-2 device is indicated for use by or under the supervision of healthcare professionals for adult
patients in a professional healthcare setting. The Echo-2 device should be used with an individual in a
supine position (including with a slightly elevated upper body). The information stored by the system may be
reviewed by qualified persons.
The Echo-2 device is not intended for continuous monitoring and is only intended for spot-check
measurements of heart rate. The Echo-2 device is not intended for use in subjects with arrhythmias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254240 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254240: Echo-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254240
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026