510(k) Report

510(k) · Cleared

Cleared

Etg-4000 Optical Topography System

K042501510(k) SpecialCleared Oct 12, 200428-day reviewClass II21 CFR 870.2700

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

Hitachi Medical Corp. · DQA Oximeter

Cleared on Oct 12, 2004 as substantially equivalent to K011320 (Hitachi Medical Systems America, Inc., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001. 67 later devices descend from it.

Decided
Oct 12, 2004
Review
28 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011320 (2001). 67 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2018: 2 descendants cleared2005: 1 descendant cleared2015: 4 descendants cleared2006: 1 descendant cleared2008: 2 descendants cleared2016: 3 descendants cleared2009: 2 descendants cleared2010: 3 descendants cleared2012: 2 descendants cleared2019: 4 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2020: 3 descendants cleared2022: 6 descendants cleared2021: 7 descendants cleared2017: 1 descendant cleared2024: 6 descendants cleared2023: 8 descendants cleared2025: 6 descendants cleared2026: 3 descendants clearedK011320 · Etg-100 Optical Encephalography System · Hitachi Medical Systems America, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 7 descendants6 generations forward: 5 descendants7 generations forward: 7 descendants8 generations forward: 6 descendants9 generations forward: 11 descendants10 generations forward: 13 descendants11 generations forward: 6 descendants K011320 · Etg-100 Optical Encephalography System · Hitachi Medical Systems America, Inc. · 20010+5+10
  1. Root · 1 generation backK011320 Etg-100 Optical Encephalography SystemHitachi Medical Systems America, Inc. · 2001
  2. This deviceK042501 Etg-4000 Optical Topography SystemHitachi Medical Corp. · 2004
  3. Descendant · cites it directly · 63 of its ownK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
  4. Descendant · 2 generations on · 59 of its ownK073036 Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008
  5. Descendant · 2 generations on · 59 of its ownK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
  6. Descendant · 3 generations on · 58 of its ownK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
  7. Descendant · 3 generations on · 57 of its ownK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 22009: 22010: 32012: 22013: 12014: 22015: 42016: 32017: 12018: 22019: 42020: 32021: 72022: 62023: 82024: 62025: 62026: 3
2005high 8 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 67 · See all
  • K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005 · cites it directly63descendants
  • K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008 · 2 generations on59descendants
  • K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006 · 2 generations on59descendants
  • K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009 · 3 generations on58descendants
  • K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009 · 3 generations on57descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011320Etg-100 Optical Encephalography SystemHitachi Medical Systems America, Inc.2001—
0 (this device)K042501Etg-4000 Optical Topography SystemHitachi Medical Corp.2004—
+1K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.2005—
+2K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.2008—
+2K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.2006—
+3K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.2009—
+3K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200820
200920
201030
201220
201310
201420
201540
201630
201710
201820
201940
202030
202170
202260
202380
202460
202560
202630
FIG. 1 — Lineage of K042501, 2001–2026Source: 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 DQA? 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 DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K011320Etg-100 Optical Encephalography SystemHitachi Medical Systems America, Inc.2001—

Also cleared against K011320: 2 other devices →

What descends from it? (67)

See all 67

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

NumberDeviceApplicantDecidedDescendants
K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563
K143219Niro-200NXHamamatsu Photonics K.K.20151
K172492Optical Topography System ETG-4100Hitachi Healthcare Americas20180

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, K051257 (Cas Medical Systems, Inc., 2005) has gone furthest, with 63 descendants of its own.
  • 2 other devices also cite its predicate K011320.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.

Indications for use as stated in the FDA summary.

Also cleared against K011320

2 other devices cite the same predicate.

  • K143219Niro-200NXHamamatsu Photonics K.K. · 2015
  • K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005

More from Hitachi Medical Corp.

11 FDA decisions under this applicant name. See the company

  • K073310Oasis CTL Coil, OD Flexible Body Coil (L and XL), and Rapid Foot CoilHitachi Medical Corp. · 2008
  • K061608Modification to Eub-5500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2006
  • K053258Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2005
  • K013722Modification to: Eub-8500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 20021 recall
  • K013723Modification to: Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 20022 recalls

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K042501 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042501: Etg-4000 Optical Topography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042501

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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