510(k) · Cleared

Cleared

Model 1310 Neurolink Neuromonitoring System

K962157510(k) TraditionalCleared Nov 25, 1996174-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

Physiometrix, Inc. · GWQ Full-Montage Standard Electroencephalograph

Cleared on Nov 25, 1996 as substantially equivalent to K930080 (Physiometrix, Inc., 1993) after a 174-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Nov 25, 1996
Review: 174 days
Class: Class II
Product code: GWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K930080 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK930080 E*Net Neuromonitoring SystemPhysiometrix, Inc. · 1993
This deviceK962157 Model 1310 Neurolink Neuromonitoring SystemPhysiometrix, Inc. · 1996
Descendant · cites it directly · 0 of its ownK970942 Model 1320, Neurolink II Neuromonitoring SystemPhysiometrix, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all

K970942Model 1320, Neurolink II Neuromonitoring SystemPhysiometrix, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930080	E*Net Neuromonitoring System	Physiometrix, Inc.	1993	—
0 (this device)	K962157	Model 1310 Neurolink Neuromonitoring System	Physiometrix, Inc.	1996	—
+1	K970942	Model 1320, Neurolink II Neuromonitoring System	Physiometrix, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K962157, 1993–1997Source: 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 GWQ? 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 GWQ device

#1 K260455 New Wave Systemscore 13.7 · 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
*	K930080	E*Net Neuromonitoring System Summary page 1 …venue N. Billerica, MA 01862 Dawn E. Frazer Director, Regulatory Affairs & Quality Assurance (508) 670-2422 (800) 474-9746 Model 1310, NeuroLink NeuroMonitoring System K930080, HydroDot NeuroMonitoring System Class Il, CFR 21 Part 882.1320, Cutaneous Electrodes Class Il, 21 CFR Part 882.1835, Physiologi…	Physiometrix, Inc.	1993	—

Also cleared against K930080: 5 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
K970942	Model 1320, Neurolink II Neuromonitoring System	Physiometrix, Inc.	1997	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, K970942 (Physiometrix, Inc., 1997) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K930080.

How does its category compare?

All GWQ devices

GWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWQ

1in 2024

2007high 8 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWQ

137in 2023

2007high 276 (2015) · low 50 (2016)2026

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

Recalls per year · GWQ

1in 2020

2007high 5 (2007) · low 0 (2011)2026

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

Adverse event reports per year · GWQ

13in 2025

2007high 30 (2020) · low 4 (2013)2025

MAUDE reports naming product code GWQ, 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	1	—	5	11
2008	2	—	2	8
2009	0	—	1	7
2010	3	73	1	12
2011	4	220	0	6
2012	4	208	0	9
2013	2	—	0	4
2014	2	—	0	7
2015	3	276	2	13
2016	3	50	0	28
2017	5	181	0	17
2018	8	150	0	15
2019	0	—	2	16
2020	6	216	1	30
2021	0	—	0	20
2022	3	216	0	16
2023	6	137	0	20
2024	1	—	0	17
2025	0	—	0	13
2026	2	—	1	—

What is it indicated for?

The NeuroLink NeuroMonitoring System has the same intended use as the predicate device, the HydroDot NeuroMonitoring System. Both are designed to locate EEG electrodes according the 10-20 International System and present electrical signal sensed by the electrodes from the skin to existing EEG recording, analysis and archiving equipment.

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/K962157 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962157: Model 1310 Neurolink Neuromonitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962157

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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