510(k) · Cleared

Cleared

Persyst Prism

K974718510(k) TraditionalCleared Mar 9, 199882-day reviewClass I21 CFR 882.1420

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

Persyst Development Corp. · GWS Analyzer, Spectrum, Electroencephalogram Signal

Cleared on Mar 9, 1998 after an 82-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Mar 9, 1998
Review: 82 days
Class: Class I
Product code: GWS
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK974718 Persyst PrismPersyst Development Corp. · 1998
Descendant · cites it directly · 1 of its ownK062533 Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK112107 Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all

K062533Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006 · cites it directly1descendant
K112107Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K974718	Persyst Prism	Persyst Development Corp.	1998	—
+1	K062533	Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524	Neurovirtual USA, Inc.	2006	—
+2	K112107	Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus	Neurovirtual USA, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2011	1	0

FIG. 1 — Lineage of K974718, 1998–2011Source: 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 GWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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
*	—	Stellate Rhythm Named without a submission number			—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K062533	Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524	Neurovirtual USA, Inc.	2006	1

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, K062533 (Neurovirtual USA, Inc., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GWS devices

GWS Analyzer, Spectrum, Electroencephalogram Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWS

FDA has decided no GWS device since 2007.

Median 510(k) review, days · GWS

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

Recalls per year · GWS

No recall names GWS since 2007.

Adverse event reports per year · GWS

1in 2017

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code GWS, not matched to any one device; reports are not rates.

View these four charts as a table

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

What is it indicated for?

This software is intended for use by a trained EEG technician or neurologist.

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/K974718 · printed Nov 3, 2026

Cite this page

510(k) Report. “K974718: Persyst Prism.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K974718

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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