510(k) · Cleared
ClearedBE Micro, Trea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eb Neuro S.P.A. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Apr 29, 2010 as substantially equivalent to K010460 (Lifelines, Ltd., 2001) and 2 other predicates after a 147-day review. Its family tree reaches back 5 generations to 1997. 4 later devices descend from it.
- Decided
- Apr 29, 2010
- Review
- 147 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K962603 (1997). 16 ancestors in all, the oldest K930790 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 2 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 1 generation backK061996 Sandman PocketEb Neuro S.P.A. · 2006
- This deviceK093728 BE Micro, TreaEb Neuro S.P.A. · 2010
- Descendant · cites it directly · 3 of its ownK133355 Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK180269 Cadwell Apollo SystemCadwell Industries, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK201819 Cadwell Apollo SystemCadwell Industries, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK221959 Q21Neurofield, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014 · cites it directly3descendants
- K180269Cadwell Apollo SystemCadwell Industries, Inc. · 2018 · 2 generations on2descendants
- K201819Cadwell Apollo SystemCadwell Industries, Inc. · 2020 · 3 generations on1descendant
- K221959Q21Neurofield, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −2 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −1 | K061996 | Sandman Pocket | Eb Neuro S.P.A. | 2006 | — |
| 0 (this device) | K093728 | BE Micro, Trea | Eb Neuro S.P.A. | 2010 | — |
| +1 | K133355 | Cadwell Flex Eeg/PSG | Cadwell Industries, Inc. | 2014 | — |
| +2 | K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018 | — |
| +3 | K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020 | — |
| +4 | K221959 | Q21 | Neurofield, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
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 OLV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K010460 | Lifelines TrackitSummary page 1…a')(3) Predicate Device(s) K# ~~~~Name Manufacturer K01 0460 Track-it Lifelines Ltd K052066 Netlink Traveler… | 2001 |
| * | K052066 | Ceegraph/Sleepscan Netlink TravelerSummary page 1…K# ~~~~Name Manufacturer K01 0460 Track-it Lifelines Ltd K052066 Netlink Traveler Bio-logic System Corp. K061 996 Sandman Pocket… | 2005 |
| * | K061996 | Sandman PocketSummary page 1…Track-it Lifelines Ltd K052066 Netlink Traveler Bio-logic System Corp. K061 996 Sandman Pocket EBNeuro Sp.A. Additional substantial equivalence information is provided below. =… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133355 | Cadwell Flex Eeg/PSG | 2014 | 3 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K133355 (Cadwell Industries, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K010460.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
BE micro/Trea intended use is collecting and recording physiological data to be used in neurology (EEG), polysomnography (PSG) and sleep disorder studies. The BE micro is intended for pediatric to adult population, and can be used either home or hospital environments
The BE micro/Trea is only to be used under the direction or supervision of a physician, or other trained health care professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093728: BE Micro, Trea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093728
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026