510(k) · Cleared

Cleared

PAM-RL

K010997510(k) TraditionalCleared Oct 15, 2001195-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

Individual Monitoring Systems, Inc. · GWQ Full-Montage Standard Electroencephalograph

Cleared on Oct 15, 2001 as substantially equivalent to K992410 (Individual Monitoring Systems, Inc., 1999) after a 195-day review. Its family tree reaches back 3 generations to 1986.

Decided: Oct 15, 2001
Review: 195 days
Class: Class II
Product code: GWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K854030 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
2 generations backK983533 ActiwatchMini-Mitter Co., Inc. · 1999 · Recalled
1 generation backK992410 ActitracIndividual Monitoring Systems, Inc. · 1999
This deviceK010997 PAM-RLIndividual Monitoring Systems, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K854030	Wrist Actigraph	Ambulatory Monitoring, Inc.	1986	—
−2	K983533	Actiwatch	Mini-Mitter Co., Inc.	1999	3
−1	K992410	Actitrac	Individual Monitoring Systems, Inc.	1999	—
0 (this device)	K010997	PAM-RL	Individual Monitoring Systems, Inc.	2001	—

FIG. 1 — Lineage of K010997, 1986–2001Source: 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
*	K992410	Actitrac Summary page 2 …tion April 2, 2001 Individual Monitoring Systems, Inc. Identification of predicate device: "ACTITRAC" - Individual Number K992410 - Monitoring Systems, INC. Product Code - GWQ Statement of intended use…	Individual Monitoring Systems, Inc.	1999	—

Also cleared against K992410: 4 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 15 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
1 of the 3 ancestors has a recall of any class.
4 other devices also cite its predicate K992410.

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 PAM-RL is a small, limb-worn activity monitor, typically placed on the leg or wrist, designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to monitor limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.

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/K010997 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010997: PAM-RL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010997

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026