510(k) · Cleared

Cleared

DeltaScan Monitor

K222680510(k) TraditionalCleared Feb 2, 2023149-day reviewClass II21 CFR 882.1440

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

Prolira B.V. · NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

Cleared on Feb 2, 2023 as substantially equivalent to DEN110019 (Lexicor Medical Technology, LLC, 2013) after a 149-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.

Decided: Feb 2, 2023
Review: 149 days
Class: Class II
Product code: NCG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN110019 (2013). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN110019 Neba SystemLexicor Medical Technology, LLC · 2013
This deviceK222680 DeltaScan MonitorProlira B.V. · 2023
Descendant · cites it directly · 0 of its ownK251936 Ceribell Delirium Monitor SystemCeribell, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all

K251936Ceribell Delirium Monitor SystemCeribell, Inc. · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN110019	Neba System	Lexicor Medical Technology, LLC	2013	—
0 (this device)	K222680	DeltaScan Monitor	Prolira B.V.	2023	—
+1	K251936	Ceribell Delirium Monitor System	Ceribell, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K222680, 2013–2025Source: 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 NCG? 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 NCG device

#1 K251936 Ceribell Delirium Monitor Systemscore 12.3 · 7 generations · no Class I recall

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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	Applicant	Decided	Recalls
*	DEN110019	Neba System Summary page 4 …Name Manufacturer De novo # NEBA system NEBA HEALTH, LLC DEN110019 IV. DEVICE DESCRIPTION Acute encephalopathy and delirium are extremely common in hospitalized patients, for exam…	Lexicor Medical Technology, LLC	2013	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K251936	Ceribell Delirium Monitor System	Ceribell, Inc.	2025	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?

Its one ancestor has no recall.
Of its descendants, K251936 (Ceribell, Inc., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NCG devices

NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · NCG

1in 2025

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NCG

Too few NCG 510(k)s in any year since 2007 to give a median.

Recalls per year · NCG

No recall names NCG since 2007.

Adverse event reports per year · NCG

No MAUDE report names NCG since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	1	—	0
2026	0	—	—

What is it indicated for?

The DeltaScan Monitor provides the binary DeltaScan Output based on a technical index of polymorphic delta (PMD) waveshape detections made in the EEG from the bipolar Fp2 and Pz channel on adult patients (over 60 years of age) to aid in the diagnosis of acute encephalopathy. DeltaScan should only be used by a healthcare provider as a component of a complete clinical evaluation or as support for the clinician's decision to pursue further testing. The…

Read the full statement (191 words)

The DeltaScan Monitor provides the binary DeltaScan Output based on a technical index of polymorphic delta (PMD)

waveshape detections made in the EEG from the bipolar Fp2 and Pz channel on adult patients (over 60 years of age) to aid

in the diagnosis of acute encephalopathy.

DeltaScan should only be used by a healthcare provider as a component of a complete clinical evaluation or as support for

the clinician's decision to pursue further testing. The device is NOT to be used as a stand-alone method in the evaluation

or diagnosis of acute encephalopathy.

The intended patient is a hospitalized, awake adult, who is at risk of acute encephalopathy and delirium as decided by the

responsible licensed healthcare physician or a medical professional working under the responsibility of a licensed

healthcare physician.

The use environment is in hospitals:

• non-sterile environments;

• ICUs, wards, and other patient evaluation locations;

The DeltaScan Monitor is intended to be used in combination with the DeltaScan Patch (K222671) through a proprietary

connector design.

Please refer to the Instructions for Use and the Instructions for Use on the Primary packaging of the DeltaScan Patch for

more information.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K222680 · printed Nov 5, 2026

Cite this page

510(k) Report. “K222680: DeltaScan Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222680

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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