510(k) · Cleared
ClearedLifelines Trackit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifelines, Ltd. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on May 14, 2001 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 14, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK010460 Lifelines TrackitLifelines, Ltd. · 2001
- Descendant · cites it directly · 4 of its ownK093728 BE Micro, TreaEb Neuro S.P.A. · 2010
- Descendant · 2 generations on · 3 of its ownK133355 Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK180269 Cadwell Apollo SystemCadwell Industries, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK201819 Cadwell Apollo SystemCadwell Industries, Inc. · 2020
- Descendant · 5 generations on · 0 of its ownK221959 Q21Neurofield, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093728BE Micro, TreaEb Neuro S.P.A. · 2010 · cites it directly4descendants
- K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014 · 2 generations on3descendants
- K180269Cadwell Apollo SystemCadwell Industries, Inc. · 2018 · 3 generations on2descendants
- K201819Cadwell Apollo SystemCadwell Industries, Inc. · 2020 · 4 generations on1descendant
- K221959Q21Neurofield, Inc. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010460 | Lifelines Trackit | Lifelines, Ltd. | 2001 | — |
| +1 | K093728 | BE Micro, Trea | Eb Neuro S.P.A. | 2010 | — |
| +2 | K133355 | Cadwell Flex Eeg/PSG | Cadwell Industries, Inc. | 2014 | — |
| +3 | K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018 | — |
| +4 | K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020 | — |
| +5 | K221959 | Q21 | Neurofield, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K093728 (Eb Neuro S.P.A., 2010) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010460 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010460: Lifelines Trackit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010460
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026