510(k) Report

510(k) · Cleared

Cleared

Navigator Pro with Aep Software (Biomark, Enog, Champ)

K083371510(k) TraditionalCleared Dec 8, 2009389-day reviewClass II21 CFR 882.1870

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Natus Medical, Inc. · GWF Stimulator, Electrical, Evoked Response

Cleared on Dec 8, 2009 as substantially equivalent to K073626 (Bio-Logic Systems Corp., 2008) and 4 other predicates after a 389-day review. Its family tree reaches back 5 generations to 1993.

Decided
Dec 8, 2009
Review
389 days
Class
Class II
Product code
GWF
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K930328 (1993). 13 ancestors in all, the oldest K844992 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2003: 2 other ancestors1985: 1 other ancestor1998: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1994: 1 other ancestorReference device: K051357 · DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH · Digitimer, Ltd. · 2005K930328 · Navigator & Traveler Evoked Postential Product · Bio-Logic Systems Corp. · 1993K992807 · Bio-Logic Evoked Potential for Abaer I · Bio-Logic Systems Corp. · 1999K994149 · Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. · Bio-Logic Systems Corp. · 1999K021895 · Bio-Logic Master Evoked Response System · Bio-Logic Systems Corp. · 2002K073626 · Bio-Logic Master II Evoked Response System · Bio-Logic Systems Corp. · 2008198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor K073626 · Bio-Logic Master II Evoked Response System · Bio-Logic Systems Corp. · 2008K021895 · Bio-Logic Master Evoked Response System · Bio-Logic Systems Corp. · 2002K994149 · Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. · Bio-Logic Systems Corp. · 1999K992807 · Bio-Logic Evoked Potential for Abaer I · Bio-Logic Systems Corp. · 1999K930328 · Navigator & Traveler Evoked Postential Product · Bio-Logic Systems Corp. · 1993−50
  1. Root · 5 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
  2. 4 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
  3. 3 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
  4. 2 generations backK021895 Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002
  5. 1 generation backK073626 Bio-Logic Master II Evoked Response SystemBio-Logic Systems Corp. · 2008
  6. This deviceK083371 Navigator Pro with Aep Software (Biomark, Enog, Champ)Natus Medical, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K930328Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp.1993—
−4K992807Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp.1999—
−3K994149Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp.1999—
−2K021895Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp.2002—
−1K073626Bio-Logic Master II Evoked Response SystemBio-Logic Systems Corp.2008—
0 (this device)K083371Navigator Pro with Aep Software (Biomark, Enog, Champ)Natus Medical, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198910
199110
199410
199810
200320
200710
FIG. 1 — Lineage of K083371, 1993–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 GWF? 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 GWF device

  1. #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 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? (5)

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
*K073626Bio-Logic Master II Evoked Response System
Summary page 1
…len Chandler Senior Consultant Date Prepared: June 5, 2009 Predicate lDevices: K073626 Bio-logic Master II Evoked Response System K03 1009 Bio-logic Evoked Potential Systemn…
Bio-Logic Systems Corp.2008—
*K031009Modification to Bio-Logic Evoked Potential (EP) System
Summary page 1
…June 5, 2009 Predicate lDevices: K073626 Bio-logic Master II Evoked Response System K03 1009 Bio-logic Evoked Potential Systemn K030907 Stacked AB3R for Navigator Pro…
Bio-Logic Systems Corp.2003—
*K030907Stacked Abr for Navigator Pro
Summary page 1
…io-logic Master II Evoked Response System K03 1009 Bio-logic Evoked Potential Systemn K030907 Stacked AB3R for Navigator Pro K070608 SnnartEP _____________________K844992…
Bio-Logic Systems Corp.2003—
*K070608Smartep, Model M010000
Summary page 1
…K03 1009 Bio-logic Evoked Potential Systemn K030907 Stacked AB3R for Navigator Pro K070608 SnnartEP _____________________K844992 Bio-logic Portable Evoked Response Systeni Device Description The EN…
Intelligent Hearing Systems2007—
*K844992Bio-Logic Portable Evoked Response System
Summary page 1
…K030907 Stacked AB3R for Navigator Pro K070608 SnnartEP _____________________K844992 Bio-logic Portable Evoked Response Systeni Device Description The ENoG Protocol is a feature of the Navigator Pro…
Bio-Logic Systems Corp.1985—
†K051357DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High…Digitimer, Ltd.2005—

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 16 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • None of the 13 ancestors has a recall.

How does its category compare?

All GWF devices

GWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GWF

1in 2025

2007: 32008: 22009: 52010: 32011: 22012: 42013: 32014: 12015: 22016: 12017: 32019: 12020: 12021: 22022: 22023: 22024: 42025: 12026 (partial year): 3
2007high 5 (2009) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWF

92in 2024

2007: 69 days median2009: 178 days median2010: 269 days median2012: 230 days median2013: 174 days median2017: 169 days median2024: 92 days median2026 (partial year): 125 days median
2007high 269 (2010) · low 69 (2007)2026

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

Recalls per year · GWF

2so far in 2026, the most since 2007

2012: 12015: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

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

Adverse event reports per year · GWF

1,034in 2025

2007: 22008: 12009: 12010: 42011: 102012: 442013: 892014: 252015: 222016: 202017: 602018: 582019: 942020: 652021: 552022: 452023: 1502024: 8542025: 1,034
2007high 1,034 (2025) · low 1 (2008)2025

MAUDE reports naming product code GWF, 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
200736902
20082—01
2009517801
2010326904
20112—010
20124230144
20133174089
20141—025
20152—122
20161—020
20173169060
20180—058
20191—094
20201—065
20212—055
20222—045
20232—0150
20244920854
20251—01,034
202631252—

What is it indicated for?

The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to the facial nerve. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.

Indications for use as stated in the FDA summary.

More from Natus Medical, Inc.

12 FDA decisions under this applicant name. See the company

  • K093304Protektor 32Natus Medical, Inc. · 20101 recall
  • K093949Olympic Brainz Monitor Model OBM70001Natus Medical, Inc. · 2010
  • K090019Natus Neuroworks, Model 104196Natus Medical, Inc. · 20101 recall
  • K073665Algo 5 Newborn Hearing ScreenerNatus Medical, Inc. · 2008
  • K051869Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc. · 2005

Recent decisions in GWF

The GWF category page

  • K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH · 2026
  • K253301BraiN20® (BraiN20)Time IS Brain, S.L. · 2026
  • K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. · 20261 recall
  • K243982Nicolet EDXNatus Neurology Incorporated · 2025
  • K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated · 2024

https://510kreport.com/device/K083371 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083371: Navigator Pro with Aep Software (Biomark, Enog, Champ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083371

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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