510(k) · Cleared

Cleared

Grass TWin

K173690510(k) SpecialCleared Mar 9, 201898-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

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · OLV Standard Polysomnograph With Electroencephalograph

Cleared on Mar 9, 2018 as substantially equivalent to K012976 (Grass-Telefactor Divison, 2002) after a 98-day review. Its family tree reaches back 2 generations to 1987.

Decided: Mar 9, 2018
Review: 98 days
Class: Class II
Product code: OLV
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K870450 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK870450 Szac-16 Seizure Analysis ComputerGrass-Telefactor Product Group · 1987
1 generation backK012976 Twin PlusGrass-Telefactor Divison · 2002
This deviceK173690 Grass TWinNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K870450	Szac-16 Seizure Analysis Computer	Grass-Telefactor Product Group	1987	—
−1	K012976	Twin Plus	Grass-Telefactor Divison	2002	—
0 (this device)	K173690	Grass TWin	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)	2018	—

FIG. 1 — Lineage of K173690, 1987–2018Source: 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? (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
*	K012976	Twin Plus Summary page 4 …edicate 510(k) Predicate Equivalent Devices: Number Manufacturer / Model XLTEK / Grass TWin K012976 Grass-Telefactor Division, Astro-Med,…	Grass-Telefactor Divison	2002	—

Also cleared against K012976: 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 31 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K012976.

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. 2018, this device’s year, is highlighted.

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?

This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, analysis, and archiving of EEG potentials and other rapidly changing physiological parameters.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173690 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173690: Grass TWin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173690

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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