510(k) · Cleared

Cleared

Cadwell AmpliScan

K161027510(k) TraditionalCleared Nov 8, 2016210-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

Cadwell Industries, Inc. · OMA Amplitude-Integrated Electroencephalograph

Cleared on Nov 8, 2016 as substantially equivalent to K132306 (Persyst Development Corp., 2013) after a 210-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.

Decided: Nov 8, 2016
Review: 210 days
Class: Class II
Product code: OMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K132306 (2013). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK132306 Persyst 12 Eeg Review and Analysis SoftwarePersyst Development Corp. · 2013
This deviceK161027 Cadwell AmpliScanCadwell Industries, Inc. · 2016
Descendant · cites it directly · 0 of its ownK190760 Cadwell Bolt SoftwareCadwell Industries, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all

K190760Cadwell Bolt SoftwareCadwell Industries, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K132306	Persyst 12 Eeg Review and Analysis Software	Persyst Development Corp.	2013	—
0 (this device)	K161027	Cadwell AmpliScan	Cadwell Industries, Inc.	2016	—
+1	K190760	Cadwell Bolt Software	Cadwell Industries, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K161027, 2013–2019Source: 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 OMA? 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 OMA device

#1 K192889 Neoscore -1.2 · 1 generation · 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
*	K132306	Persyst 12 Eeg Review and Analysis Software Summary page 4 …n Name: Electroencephalograph (21 CFR 882.1400) Regulatory Classification: Class II Product Code: OMA 3) Predicate Device: Persyst 12 EEG Review and Analysis Software (K132306) is a predicate. This predicate has not been subject to a design-related recall. Olympic CFM6000 (K031149) is a reference predic…	Persyst Development Corp.	2013	—
†	K031149	Olympic CFM 6000	Olympic Medical Corp.	2003	—

Also cleared against K132306: 4 other devices →

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
K190760	Cadwell Bolt Software	Cadwell Industries, Inc.	2019	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, K190760 (Cadwell Industries, Inc., 2019) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K132306.

How does its category compare?

All OMA devices

OMA Amplitude-Integrated Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · OMA

1in 2020

2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMA

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

Recalls per year · OMA

No recall names OMA since 2007.

Adverse event reports per year · OMA

2in 2024

2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code OMA, 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	1	—	0
2008	2	—	0
2009	0	—	0
2010	2	—	0
2011	0	—	0
2012	1	—	0
2013	2	—	0
2014	0	—	0
2015	1	—	0
2016	2	—	1
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	1	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	2
2025	0	—	0
2026	0	—	—

What is it indicated for?

1) Cadwell AmpliScan is a software-only device indicated for use with electroencephalographic (EEG) data from Cadwell Arc application software. Cadwell AmpliScan is distributed solely for use with Cadwell Arc software. 2) The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information. 3) This device does not provide any…

Read the full statement (122 words)

2) The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information.

3) This device does not provide any diagnostic conclusion about the patient’s condition to the user.

4) Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a quantitative aEEG measure. This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms. The aEEG quantitative measure of Cadwell AmpliScan is intended to monitor the state of the brain.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161027 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161027: Cadwell AmpliScan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161027

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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