510(k) · Cleared

Cleared

GSI Novus

K172403510(k) TraditionalCleared Oct 20, 201772-day reviewClass II21 CFR 874.1050

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

Cleared on Oct 20, 2017 as substantially equivalent to K103760 (Interacoustics A/S, 2011) and 1 other predicate after a 72-day review. Its family tree reaches back 3 generations to 2006.

Decided: Oct 20, 2017
Review: 72 days
Class: Class II
Product code: EWO
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K060539 (2006). 5 ancestors in all, the oldest K052562 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK060539 DPOAE20 , EclipseInteracoustics A/S, Assens · 2006
2 generations backK103760 TITANInteracoustics A/S · 2011
1 generation backK130795 TITANInteracoustics A/S · 2013
This deviceK172403 GSI NovusGrason-Stadler, Inc. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K060539	DPOAE20 , Eclipse	Interacoustics A/S, Assens	2006	—
−2	K103760	TITAN	Interacoustics A/S	2011	—
−1	K130795	TITAN	Interacoustics A/S	2013	—
0 (this device)	K172403	GSI Novus	Grason-Stadler, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	1	0

FIG. 1 — Lineage of K172403, 2006–2017Source: 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 EWO? 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 EWO device

#1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 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
*	K103760	TITAN Summary page 4 …Throat / Neurology Classification Regulation: 874.1050/882.1900 Product Code: EWO/GWJ Predicate Device 1: Titan (with DPOAE440 and ABRIS440), cleared on 05/05/2011 via K103760 Predicate Device 2: Titan (with TEOAE440), cleared on 06/20/2013 via K130795 Device Description The device is audiometric equip…	Interacoustics A/S	2011	—
*	K130795	TITAN Summary page 4 …: EWO/GWJ Predicate Device 1: Titan (with DPOAE440 and ABRIS440), cleared on 05/05/2011 via K103760 Predicate Device 2: Titan (with TEOAE440), cleared on 06/20/2013 via K130795 Device Description The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities. Nov…	Interacoustics A/S	2013	—

Also cleared against K103760: 3 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 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
None of the 5 ancestors has a recall.
3 other devices also cite its predicate K103760.

How does its category compare?

All EWO devices

EWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · EWO

2in 2024

2007high 5 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EWO

173in 2015

2007high 173 (2015) · low 69 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EWO

4in 2023

2007high 4 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EWO

13in 2025

2007high 13 (2025) · low 0 (2012)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	69	0	1
2008	1	—	1	1
2009	2	—	0	1
2010	2	—	0	4
2011	3	151	0	2
2012	4	137	0	0
2013	2	—	0	0
2014	1	—	0	0
2015	4	173	0	1
2016	0	—	0	0
2017	2	—	0	0
2018	2	—	0	0
2019	1	—	0	6
2020	0	—	0	7
2021	0	—	0	3
2022	1	—	0	6
2023	1	—	4	3
2024	2	—	0	2
2025	0	—	0	13
2026	0	—	0	—

What is it indicated for?

The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, identification, documentation and diagnosis of auditory and hearing related disorders. The auditory evoked response (ABR) measurement is intended for newborns and infants…

Read the full statement (135 words)

The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172403: GSI Novus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172403

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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