510(k) · Cleared
Recalled · 2007Enfanttm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diopsys, Inc. · GWE Stimulator, Photic, Evoked Response
Cleared on Mar 16, 2005 as substantially equivalent to K863956 (Doran Instruments, Inc., 1986) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1976. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 16, 2005
- Review
- 89 days
- Class
- Class II
- Product code
- GWE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K760199 (1976). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK760199 ElectroretinographLkc Technologies, Inc. · 1976
- 1 generation backK983983 Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999
- This deviceK043491 EnfanttmDiopsys, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK101763 Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K101763Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K760199 | Electroretinograph | Lkc Technologies, Inc. | 1976 | — |
| −1 | K983983 | Edi Veris System | Electro-Diagnostic Imaging, Inc. | 1999 | — |
| 0 (this device) | K043491 | Enfanttm | Diopsys, Inc. | 2005 | — |
| +1 | K101763 | Diopsys Nova Vep Vision Testing System | Diopsys, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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 GWE? 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 GWE device
- #1 K211643 Vision Monitor - MonpackONEscore 5.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863956 | Maculoscope (TM)Summary page 1…duct codes: GWE, GWQ,GWL 1.1 Identification of Legally Marked Device The EnfantTM System is substantially equivalent to the Maculoscope and the Espion System(K863956) both manufactured by Doran (aka Diagnosys LLC) and the VERIS system(K983983) manufactured by Electro-Diagnostic Imaging, In… | 1986 |
| * | K983983 | Edi Veris SystemSummary page 1…fantTM System is substantially equivalent to the Maculoscope and the Espion System(K863956) both manufactured by Doran (aka Diagnosys LLC) and the VERIS system(K983983) manufactured by Electro-Diagnostic Imaging, Inc. These are hardware and software products. The EnfantTm device is substanti… | 1999 |
| * | — | Maculoscope Named without a submission number | |
| † | K023525 | Retiscan, Retiport | 2004 |
| † | K880773 | The Venus System | 1988 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101763 | Diopsys Nova Vep Vision Testing System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2007 | Not classified | Z-1437-2010 | Software design | The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 22.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K101763 (Diopsys, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K863956.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWE
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GWE
Too few GWE 510(k)s in any year since 2007 to give a median.
Recalls per year · GWE
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWE
1in 2025
MAUDE reports naming product code GWE, 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 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Enfant is a non-invasive medical device to screen, without dilation or sedation, for visual disorders in infants and pre-school children. The system uses Visual Evoked potentials to provide information about the visual pathway function and about optical or neural abnormalities related to vision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043491: Enfanttm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043491
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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