510(k) Report

510(k) · Cleared

Cleared

Ambulatory Eeg/Sleep Recorder and Accessories, Model # SSR3201

K983072510(k) TraditionalCleared Dec 1, 199890-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

Nihon Kohden America, Inc. · OLV Standard Polysomnograph With Electroencephalograph

Cleared on Dec 1, 1998 as substantially equivalent to K962103 (Bio-Logic Systems Corp., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1994.

Decided
Dec 1, 1998
Review
90 days
Class
Class II
Product code
OLV
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K930790 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestorK930790 · Addition of Built-in Oxymeter to Sleepscan Prod. · Bio-Logic Systems Corp. · 1994K962103 · Bio-Logic Sleepscan Product with Built-in Oximeter · Bio-Logic Systems Corp. · 1996199019921994199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K962103 · Bio-Logic Sleepscan Product with Built-in Oximeter · Bio-Logic Systems Corp. · 1996K930790 · Addition of Built-in Oxymeter to Sleepscan Prod. · Bio-Logic Systems Corp. · 19940
  1. Root · 2 generations backK930790 Addition of Built-in Oxymeter to Sleepscan Prod.Bio-Logic Systems Corp. · 1994
  2. 1 generation backK962103 Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 1996
  3. This deviceK983072 Ambulatory Eeg/Sleep Recorder and Accessories, Model # SSR3201Nihon Kohden America, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K930790Addition of Built-in Oxymeter to Sleepscan Prod.Bio-Logic Systems Corp.1994—
−1K962103Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp.1996—
0 (this device)K983072Ambulatory Eeg/Sleep Recorder and Accessories, Model # SSR3201Nihon Kohden America, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
FIG. 1 — Lineage of K983072, 1994–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241288 Noxturnal Webscore 17.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K962103Bio-Logic Sleepscan Product with Built-in Oximeter
Summary page 1
…e Electroencephalograph, Ambulatory EEG Recorder and Ambulatory Sleep Recorder. The predicate devices are Bio-logic Systems Corporation's Sleepscan Traveler per 510(k) #K962103, commerclal distribution certification dated August 22, 1996 and Oxford Instruments Medilog MR95 per 510(k) #K961642, commercial…
Bio-Logic Systems Corp.1996—
*K961642Medilog MR95
Summary page 1
…Systems Corporation's Sleepscan Traveler per 510(k) #K962103, commerclal distribution certification dated August 22, 1996 and Oxford Instruments Medilog MR95 per 510(k) #K961642, commercial distribution certification dated January 17, 1997. The SSR3201 is intended for medical purposes to record electrical…
Oxford Instruments, Plc.1997—

Also cleared against K962103: 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 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
  • None of the 4 ancestors has a recall.
  • 2 other devices also cite its predicate K962103.

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.

FDA decisions per year · OLV

1in 2025

2008: 22010: 12011: 22013: 12015: 12017: 32018: 32020: 22022: 12024: 22025: 12026 (partial year): 2
2007high 3 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLV

141in 2018

2017: 83 days median2018: 141 days median
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

2013: 12016: 42018: 32019: 12021: 32022: 32023: 22024: 22025: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—00
20101—00
20112—00
20120—00
20131—01
20140—00
20151—00
20160—04
201738300
2018314103
20190—01
20202—00
20210—03
20221—03
20230—02
20242—02
20251—01
20262—0—

What is it indicated for?

The SSR3201 Ambulatory EEG/Sleep Recorder is Intended for medical purpeses to record electrical activity of the brain (EEG) and to record physlological data required for sleep studies (Polysomnography or PSG). These studies Including EEG, eye movement (EQG), resplratory signals such as air flow or air pressure and thoraco-abdominal movement, chin and arm/leg movement (EMG), body position, EKG and blood oxygen saturation. The device does not provide…

Read the full statement (141 words)

The SSR3201 Ambulatory EEG/Sleep Recorder is Intended for medical purpeses to record

electrical activity of the brain (EEG) and to record physlological data required for sleep studies

(Polysomnography or PSG). These studies Including EEG, eye movement (EQG), resplratory

signals such as air flow or air pressure and thoraco-abdominal movement, chin and arm/leg

movement (EMG), body position, EKG and blood oxygen saturation. The device does not

provide alarms and can not be used as an automated apnea monitor.

This device Is intended to record up to 24 hours of continuous patient data for

freely-moving or sleeping patients both inside and outside of a medical facility. The

SSR3201 is Intended to record patient data for later review by a medical professional

using a legally marketed digital EEG/PSG system to assist in diagnosing EEG related

conditions such as epilepsy and sleep related breathing

disorders.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K962103

2 other devices cite the same predicate.

  • K052066Ceegraph/Sleepscan Netlink TravelerBio-Logic Systems Corp. · 20052 recalls
  • K012437Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002

More from Nihon Kohden America, Inc.

166 FDA decisions under this applicant name. See the company

  • K113117Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction BoxNihon Kohden America, Inc. · 2012
  • K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012
  • K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
  • K083456Nihon Kohden CO2 Sensor Kit, Model TG-970PNihon Kohden America, Inc. · 2009
  • K083271BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series Optional AccessoryNihon Kohden America, Inc. · 2008

Recent decisions in OLV

The OLV category page

  • K261747Report StudioBeacon Biosignals, Inc. · 2026
  • K260585Noxturnal WebNox Medical Ehf · 2026
  • K242447Falcon HSTCompumedics Limited · 2025
  • K241288Noxturnal WebNox Medical Ehf · 2024
  • K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH · 2024

https://510kreport.com/device/K983072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983072: Ambulatory Eeg/Sleep Recorder and Accessories, Model # SSR3201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983072

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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