510(k) · Cleared
ClearedEndolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Devices, Inc. · MPA Endoilluminator
Cleared on Jun 24, 1997 after a 106-day review. The FDA summary names no predicate by number. 14 later devices descend from it.
- Decided
- Jun 24, 1997
- Review
- 106 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK970882 Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.)American Medical Devices, Inc. · 1997
- Descendant · cites it directly · 10 of its ownK041108 Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004
- Descendant · cites it directly · 9 of its ownK080067 Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · Recalled
- Descendant · 2 generations on · 6 of its ownK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK991323 Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K041108Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004 · cites it directly10descendants
- K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · cites it directly9descendants
- K173332OMNI Surgical SystemSight Sciences, Inc. · 2017 · 2 generations on6descendants
- K202678OMNI Surgical SystemSight Sciences, Inc. · 2021 · 3 generations on2descendants
- K991323Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970882 | Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.) | American Medical Devices, Inc. | 1997 | — |
| +1 | K041108 | Iscience Surgical Ophthalmic Microcannula | Iscience Surgical Corporation | 2004 | — |
| +1 | K080067 | Iscience Interventional Ophthalmic Microcatheter | Iscience Interventional | 2008 | 2 |
| +2 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| +3 | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
| +1 | K991323 | Smith & Nephew Subcutaneous Illuminator | Smith & Nephew, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 MPA? 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 MPA device
- #1 K253468 Nova Eye iTrack™ 250A Canaloplasty…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (14)
See all 143 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, K041108 (Iscience Surgical Corporation, 2004) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MPA devicesMPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MPA
Too few MPA 510(k)s in any year since 2007 to give a median.
Recalls per year · MPA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPA
11in 2025
MAUDE reports naming product code MPA, 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 | — | 0 | 4 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 62 |
| 2025 | 0 | — | 1 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For illumination and irrigation/aspiration during surgery.
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/K970882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970882: Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970882
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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