510(k) · Cleared
ClearedPanoptic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Dec 20, 2012 as substantially equivalent to K110986 (Optomed OY, 2011) and 3 other predicates after a 224-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Dec 20, 2012
- Review
- 224 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K003376 (2001). 14 ancestors in all, the oldest K912891 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003376 Welch Allyn 11800 OpthalmoscopeWelch Allyn, Inc. · 2001
- 2 generations backK092056 Optomed Smartscope, Model M3-1 EY1Optomed OY · 2009
- 1 generation backK110986 Optomed Smartscope M5 EY3 and M5 ES1Optomed OY · 2011
- This deviceK121405 PanopticWelch Allyn, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK223381 iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223381iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003376 | Welch Allyn 11800 Opthalmoscope | Welch Allyn, Inc. | 2001 | — |
| −2 | K092056 | Optomed Smartscope, Model M3-1 EY1 | Optomed OY | 2009 | — |
| −1 | K110986 | Optomed Smartscope M5 EY3 and M5 ES1 | Optomed OY | 2011 | — |
| 0 (this device) | K121405 | Panoptic | Welch Allyn, Inc. | 2012 | — |
| +1 | K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 HKI? 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 HKI device
- #1 K253176 TearViewscore 12.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K110986 | Optomed Smartscope M5 EY3 and M5 ES1Summary page 1…Code: HKI Predicate Devices: Optomed Smartscope M5 EY3, Smartscope M5 ES I Optomed Oy 510(k) KI 110986 KOWA Genesis-D KOWA CO.LTD 5l10(k) K080681… | 2011 |
| * | K080681 | Kowa Genesis-DSummary page 1…d Oy 510(k) KI 110986 KOWA Genesis-D KOWA CO.LTD 5l10(k) K080681 EyeQuick EyeQuick, LLC 5 10(k) K 102412… | 2008 |
| * | K102412 | Vista Digital OpthalmoscopeSummary page 1…WA CO.LTD 5l10(k) K080681 EyeQuick EyeQuick, LLC 5 10(k) K 102412 Welch Allyn PanOptic #11800 Welch Allyn, Inc.… | 2011 |
| * | K003376 | Welch Allyn 11800 OpthalmoscopeSummary page 1…5 10(k) K 102412 Welch Allyn PanOptic #11800 Welch Allyn, Inc. 5 10(k) K003 376 WelcIhAlyi Description of Device: The Welch A]llyn iExaminer is comprised of the adapter, the iPhone and the sof… | 2001 |
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 |
|---|---|---|---|
| K223381 | iExaminer System with Panoptic Plus | 2023 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K223381 (Welch Allyn, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K110986.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The iExaminer is an attachment and software used only with the iPhone 4 and iPhone 4S in conjunction with the Welch Allyn PanOptic Ophthalmoscope to allow users to capture, send, store and retrieve images of the eye. The device is intended to be used by trained personnel within a medical or school environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121405: Panoptic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121405
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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