510(k) · Cleared
ClearedEtg-100 Optical Encephalography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · DQA Oximeter
Cleared on Aug 9, 2001 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.
- Decided
- Aug 9, 2001
- Review
- 100 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 3 citing it directly.
- This deviceK011320 Etg-100 Optical Encephalography SystemHitachi Medical Systems America, Inc. · 2001
- Descendant · cites it directly · 67 of its ownK042501 Etg-4000 Optical Topography SystemHitachi Medical Corp. · 2004
- Descendant · cites it directly · 63 of its ownK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 59 of its ownK073036 Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 59 of its ownK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 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
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K042501Etg-4000 Optical Topography SystemHitachi Medical Corp. · 2004 · cites it directly67descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011320 | Etg-100 Optical Encephalography System | Hitachi Medical Systems America, Inc. | 2001 | — |
| +1 | K042501 | Etg-4000 Optical Topography System | Hitachi Medical Corp. | 2004 | — |
| +1 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| +2 | K073036 | Fore-Sight, MC-2000 Series | Cas Medical Systems, Inc. | 2008 | — |
| +2 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| +3 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (68)
See all 683 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K042501 (Hitachi Medical Corp., 2004) has gone furthest, with 67 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
https://510kreport.com/device/K011320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011320: Etg-100 Optical Encephalography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011320
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026