510(k) · Cleared
ClearedZmachine, Model DT-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consolidated Research of Richmond, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Mar 31, 2011 as substantially equivalent to K021485 (Oxford Biosignals Limited, 2002) after a 273-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it.
- Decided
- Mar 31, 2011
- Review
- 273 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021485 (2002). 10 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK021485 BiosomniaOxford Biosignals Limited · 2002
- This deviceK101830 Zmachine, Model DT-100Consolidated Research of Richmond, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK142834 DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK172986 Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO · 2017
- Descendant · 2 generations on · 1 of its ownK192549 Byteflies KitByteflies NV · 2020
- Descendant · 3 generations on · 0 of its ownK254213 Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc. · 2015 · cites it directly5descendants
- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · 2 generations on2descendants
- K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO · 2017 · cites it directly2descendants
- K192549Byteflies KitByteflies NV · 2020 · 2 generations on1descendant
- K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021485 | Biosomnia | Oxford Biosignals Limited | 2002 | — |
| 0 (this device) | K101830 | Zmachine, Model DT-100 | Consolidated Research of Richmond, Inc. | 2011 | — |
| +1 | K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015 | — |
| +2 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
| +1 | K172986 | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | 2017 | — |
| +2 | K192549 | Byteflies Kit | Byteflies NV | 2020 | — |
| +3 | K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K021485 | BiosomniaSummary page 2…very 30 seconds. Substantial Equivalence The Zmachine is substantially equivalent to the Oxford BioSignals Biosomnia device. manufactured by Oxford Biosignals Limited (K02 1485). The table below summarizes the technological characteristics of the Zmachine in comparison to the predicate device. D… | 2002 |
What descends from it? (10)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K142834 (Neurowave Systems, Inc., 2015) has gone furthest, with 5 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. 2011, 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?
The CR1 Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101830: Zmachine, Model DT-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101830
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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