510(k) · Cleared

Cleared

Panbus Digital Eeg & Sleep Acquisition Devices

K042364510(k) SpecialCleared Sep 30, 200430-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 Sep 30, 2004 as substantially equivalent to K990522 (Lamont Medical, Inc., 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 2000.

Decided: Sep 30, 2004
Review: 30 days
Class: Class II
Product code: OLV
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K001324 (2000). 3 ancestors in all, the oldest K990522 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK001324 Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps…Neuro Scan Labs · 2000
1 generation backK023771 SYNAMPS2Neuroscan · 2003
This deviceK042364 Panbus Digital Eeg & Sleep Acquisition DevicesLamont Medical, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K001324	Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256…	Neuro Scan Labs	2000	—
−1	K023771	SYNAMPS2	Neuroscan	2003	—
0 (this device)	K042364	Panbus Digital Eeg & Sleep Acquisition Devices	Lamont Medical, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K042364, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K990522	Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse… Summary page 1 …27-8600 September 24, 2004 PANBUS® Digital EEG and Sleep Acquisition Devices Electroencephalograph OkV¢ Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class I K990522 WARATAH and CARDINAL Digital EEG and Sleep Acquisition Devices K023771Neuroscan SynAmps® 1.0 Description of Device Like the pre…	Lamont Medical, Inc.	1999	—
*	K023771	SYNAMPS2 Summary page 1 …ices Electroencephalograph OkV¢ Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class I K990522 WARATAH and CARDINAL Digital EEG and Sleep Acquisition Devices K023771Neuroscan SynAmps® 1.0 Description of Device Like the predicate WARATAH® and Cardinal® Digital EEG and Sleep Acquisition Devices…	Neuroscan	2003	—

Also cleared against K990522: 2 other devices →

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?

The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K990522.

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 Neurophysiologist or the equivalent or Ph.D. level Electroencephalographers.

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

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/K042364 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042364: Panbus Digital Eeg & Sleep Acquisition Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042364

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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