510(k) Report

510(k) · Cleared

Cleared

EMBLA

K971813510(k) TraditionalCleared Jan 16, 1998245-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

Ferguson Medical · OLV Standard Polysomnograph With Electroencephalograph

Cleared on Jan 16, 1998 as substantially equivalent to K922106 (Healthdyne, Inc., 1994) and 7 other predicates after a 245-day review. Its family tree reaches back 1 generation to 1983. 61 later devices descend from it.

Decided
Jan 16, 1998
Review
245 days
Class
Class II
Product code
OLV
Recalls
None
Predicates
8

Its longest line of descent runs back 1 generation to K830295 (1983). 8 ancestors in all. 61 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1986: 1 other ancestor1999: 2 descendants cleared2009: 3 descendants cleared2016: 4 descendants cleared2008: 2 descendants cleared2007: 1 descendant cleared2011: 2 descendants cleared2010: 2 descendants cleared2014: 2 descendants cleared2021: 3 descendants cleared2020: 2 descendants cleared2017: 1 descendant cleared2025: 9 descendants cleared2012: 1 descendant cleared2018: 3 descendants cleared2026: 8 descendants cleared2022: 6 descendants cleared2024: 3 descendants cleared2023: 4 descendants cleared2013: 1 descendant cleared2019: 2 descendants clearedK830295 · Medilog 9000 System · Oxford Medilog, Inc. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors 1 generation forward: 7 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 11 descendants5 generations forward: 13 descendants6 generations forward: 8 descendants7 generations forward: 4 descendants8 generations forward: 2 descendants9 generations forward: 2 descendants K830295 · Medilog 9000 System · Oxford Medilog, Inc. · 19830+5
  1. Root · 1 generation backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
  2. This deviceK971813 EMBLAFerguson Medical · 1998
  3. Descendant · cites it directly · 25 of its ownK080427 Watch-Pat Model 100S-2Itamar Medical · 2008
  4. Descendant · 2 generations on · 24 of its ownK081982 Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008
  5. Descendant · cites it directly · 23 of its ownK102567 Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011
  6. Descendant · cites it directly · 23 of its ownK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
  7. Descendant · 2 generations on · 22 of its ownK133859 Watch-PAT200U (WP200U)Itamar Medical, Ltd. · 2014

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

1999: 22007: 12008: 22009: 32010: 22011: 22012: 12013: 12014: 22016: 42017: 12018: 32019: 22020: 22021: 32022: 62023: 42024: 32025: 92026: 8
1999high 9 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 61 · See all
  • K080427Watch-Pat Model 100S-2Itamar Medical · 2008 · cites it directly25descendants
  • K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008 · 2 generations on24descendants
  • K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011 · cites it directly23descendants
  • K070375Earlysense ES-16 SystemEarlysense, Ltd. · 2007 · cites it directly23descendants
  • K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd. · 2014 · 2 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830295Medilog 9000 SystemOxford Medilog, Inc.1983—
0 (this device)K971813EMBLAFerguson Medical1998—
+1K080427Watch-Pat Model 100S-2Itamar Medical2008—
+2K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical2008—
+1K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.2011—
+1K070375Earlysense ES-16 SystemEarlysense, Ltd.2007—
+2K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199110
199210
199410
199520
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200710
200820
200930
201020
201120
201210
201310
201420
201640
201710
201830
201920
202020
202130
202260
202340
202430
202590
202680
FIG. 1 — Lineage of K971813, 1983–2026Source: 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? (8)

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
*K922106ALICE
Summary page 1
…mmon/usual name: Electroencephalagraph, EEG monitor, EEG recorder, sleep recorder, etc. Proprietary name: Embla B. Substantial equivalence: Healthdyne, Inc. Alice 3., (K922106) ., Healthdyne, Inc. Alice 4, (K971867), SensorMedics Corp. Sensormedics 4000 Series Sleep System (K915856), New England Medical…
Healthdyne, Inc.19941
*K971867Alice 4R System
Cleared while this submission was under review
Summary page 1
…EEG monitor, EEG recorder, sleep recorder, etc. Proprietary name: Embla B. Substantial equivalence: Healthdyne, Inc. Alice 3., (K922106) ., Healthdyne, Inc. Alice 4, (K971867), SensorMedics Corp. Sensormedics 4000 Series Sleep System (K915856), New England Medical Instruments, Inc. DigiTrace Home Monito…
Healthdyne Technologies, Inc.1997—
*K915856Sensormedics 4000 Series Sleep System
Summary page 1
…Embla B. Substantial equivalence: Healthdyne, Inc. Alice 3., (K922106) ., Healthdyne, Inc. Alice 4, (K971867), SensorMedics Corp. Sensormedics 4000 Series Sleep System (K915856), New England Medical Instruments, Inc. DigiTrace Home Monitoring Monitoring Computer/ELB EEG Lunch Box (K910771), New England Me…
Sensor Medics Corp.1992—
*K910771Digitrace (TM) Home Monit Comp/Elb (TM) Eeg Lunch BX
Summary page 1
…ensorMedics Corp. Sensormedics 4000 Series Sleep System (K915856), New England Medical Instruments, Inc. DigiTrace Home Monitoring Monitoring Computer/ELB EEG Lunch Box (K910771), New England Medical Monitoring Company DigiTrace Sleep Computer (K944833), Cadwell Laboratories, Inc. Easy Ambulatory EEG (K946…
New England Medical Instruments, Inc.1991—
*K944833Digitrace Sleep Computer, Sleeppac, Home Sleep System
Summary page 1
…and Medical Instruments, Inc. DigiTrace Home Monitoring Monitoring Computer/ELB EEG Lunch Box (K910771), New England Medical Monitoring Company DigiTrace Sleep Computer (K944833), Cadwell Laboratories, Inc. Easy Ambulatory EEG (K946094), Oxford Medilog, Inc. Medilog 9000 System (K830295), Oxford Medilog, I…
New England Medical Monitoring Co.1995—
*K946094Cadwell Easy Ambulatory Eeg
Summary page 1
…nitoring Computer/ELB EEG Lunch Box (K910771), New England Medical Monitoring Company DigiTrace Sleep Computer (K944833), Cadwell Laboratories, Inc. Easy Ambulatory EEG (K946094), Oxford Medilog, Inc. Medilog 9000 System (K830295), Oxford Medilog, Inc. Model 9000 Recording & Electrophysiology System (K8604…
Cadwell Laboratories, Inc.1995—
*K830295Medilog 9000 System
Summary page 1
…ngland Medical Monitoring Company DigiTrace Sleep Computer (K944833), Cadwell Laboratories, Inc. Easy Ambulatory EEG (K946094), Oxford Medilog, Inc. Medilog 9000 System (K830295), Oxford Medilog, Inc. Model 9000 Recording & Electrophysiology System (K860456), and others. C. Device Description: The device…
Oxford Medilog, Inc.1983—
*K860456Model 9000 Recording & Electrophysiological System
Summary page 1
…boratories, Inc. Easy Ambulatory EEG (K946094), Oxford Medilog, Inc. Medilog 9000 System (K830295), Oxford Medilog, Inc. Model 9000 Recording & Electrophysiology System (K860456), and others. C. Device Description: The device is an EEG and physiological signs recorder. D. Intended use: Embla is a polysom…
Oxford Medilog, Inc.1986—

What descends from it? (61)

See all 61

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080427Watch-Pat Model 100S-2Itamar Medical200825
K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.201123
K070375Earlysense ES-16 SystemEarlysense, Ltd.200723
K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097
K984580Biosaca SystemBiosys AB (Publ)19991
K162140RemLogicEmbla Systems20160
K991446Biosaca System, Model 800Biosys AB (Publ)19990

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?

  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K080427 (Itamar Medical, 2008) has gone furthest, with 25 descendants of its own.

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?

Embla is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where patients require documentation of various sleep or other physiological disorders.

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

More from Ferguson Medical

57 FDA decisions under this applicant name. See the company

  • K033153Dicom TheaterFerguson Medical · 2004
  • K962615Tumorlocalizer MriFerguson Medical · 1998
  • K963794PunctureneedleFerguson Medical · 1998
  • K972219Orthopedic Plate SystemFerguson Medical · 1997
  • K972217Orthopedic Screw SystemFerguson Medical · 1997

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/K971813 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971813: EMBLA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971813

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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