510(k) · Cleared
ClearedOmnipro System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mays and Associates, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Feb 1, 2005 as substantially equivalent to K000068 (Compumedics Neuro Science Pty, Ltd., 2000) and 1 other predicate after an 11-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Feb 1, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946094 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK946094 Cadwell Easy Ambulatory EegCadwell Laboratories, Inc. · 1995
- This deviceK050143 Omnipro SystemMays and Associates, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946094 | Cadwell Easy Ambulatory Eeg | Cadwell Laboratories, Inc. | 1995 | — |
| 0 (this device) | K050143 | Omnipro System | Mays and Associates, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K000068 | Compumedics E-Series Eeg SystemSummary page 1…Consultant E-mail: harvey~delphiconsulting.com 3. Predicate Device: Compumedics E-Series EEG System, K000068, Compumedics Neuro Science Pty LTD, Minneapolis, MN 55432 and Cadwell Easy IISystem K946094, Cadwell Laborato… | 2000 |
| * | K946094 | Cadwell Easy Ambulatory EegSummary page 1…3. Predicate Device: Compumedics E-Series EEG System, K000068, Compumedics Neuro Science Pty LTD, Minneapolis, MN 55432 and Cadwell Easy IISystem K946094, Cadwell Laboratories, Inc., Kennewick, WA 99336. 4. Classifications Names & Citations: Electroencepha… | 1995 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K000068.
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 | — |
What is it indicated for?
The OmniProTM System is intended for the measuring, recording and analysis of the electrical activity of a patient's brain through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG/EMG/EOG/ECG/Air Flow/Oximetry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050143 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050143: Omnipro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050143
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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