510(k) · Cleared

Cleared

Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital Eeg and Sleep Acquis

K990522510(k) TraditionalCleared May 19, 199990-day reviewClass II21 CFR 882.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lamont Medical, Inc. · OLV Standard Polysomnograph With Electroencephalograph

Cleared on May 19, 1999 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 61 later devices descend from it.

Decided: May 19, 1999
Review: 90 days
Class: Class II
Product code: OLV
Recalls: None
Predicates: 0

61 later devices descend from it, 3 citing it directly.

This deviceK990522 Waratah Digital Eeg and Sleep Acquisition Devices with, or Without…Lamont Medical, Inc. · 1999
Descendant · cites it directly · 39 of its ownK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
Descendant · 2 generations on · 34 of its ownK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
Descendant · 3 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
Descendant · cites it directly · 19 of its ownK061908 Nicoletone System V32 AmplifierViasys Neuro Care · 2006
Descendant · 4 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2003high 8 (2011) · low 0 (2019)2026

Most influential descendants

Showing 5 of 61 · See all

K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003 · cites it directly39descendants
K041308Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004 · 2 generations on34descendants
K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 3 generations on25descendants
K061908Nicoletone System V32 AmplifierViasys Neuro Care · 2006 · cites it directly19descendants
K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 4 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990522	Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse…	Lamont Medical, Inc.	1999	—
+1	K022274	Carecompanion Patient Station & Nurse Station	Neptec Design Group, Ltd.	2003	—
+2	K041308	Remotenurse Patient Monitoring System	Webvmc, LLC	2004	—
+3	K080798	Intel Health Guide, Model: PHS6000	Intel Corp.	2008	—
+1	K061908	Nicoletone System V32 Amplifier	Viasys Neuro Care	2006	—
+4	K083862	Medapps 2.0 Remote Patient Monitoring System	Medapps, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2005	1	0
2006	1	0
2007	1	0
2008	2	0
2009	2	0
2010	4	0
2011	8	0
2012	4	0
2013	6	0
2014	2	0
2015	3	0
2016	1	0
2017	7	0
2018	2	0
2020	3	0
2022	3	0
2023	3	0
2024	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K990522, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (61)

See all 61

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022274	Carecompanion Patient Station & Nurse Station	Neptec Design Group, Ltd.	2003	39
K061908	Nicoletone System V32 Amplifier	Viasys Neuro Care	2006	19
K042364	Panbus Digital Eeg & Sleep Acquisition Devices	Lamont Medical, Inc.	2004	0

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, K022274 (Neptec Design Group, Ltd., 2003) has gone furthest, with 39 descendants of its own.

How does its category compare?

All OLV devices

OLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLV

1in 2025

2007high 3 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLV

141in 2018

2007high 141 (2018) · low 83 (2017)2026

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

2007high 4 (2016) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	2	—	0
2009	0	—	0
2010	1	—	0
2011	2	—	0
2012	0	—	0
2013	1	—	1
2014	0	—	0
2015	1	—	0
2016	0	—	4
2017	3	83	0
2018	3	141	3
2019	0	—	1
2020	2	—	0
2021	0	—	3
2022	1	—	3
2023	0	—	2
2024	2	—	2
2025	1	—	1
2026	2	—	—

What is it indicated for?

For long term unattended EEG or other electrophysiological signal monitoring and recording.

This device is intended for use by physicians skilled in electroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologists or the equivalent or Ph.D. level Electroencephalographers.

We recommend placement of electrodes in accordance with the 10.20 International System.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990522 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990522: Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital Eeg and Sleep Acquis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990522

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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