510(k) · Cleared
Cleared23ga Chandelier Illuminator, 25ga Chandelier Illuminator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peregrine Surgical, Ltd. · MPA Endoilluminator
Cleared on Sep 11, 2015 as substantially equivalent to K980025 (Peregrine Surgical, Ltd., 1998) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 11, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954307 (1995). 7 ancestors in all, the oldest K931784 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK954307 Gamp & Assoc. Disposable Endoocular Laser ProbeGamp & Assoc. · 1995
- 3 generations backK024061 Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003
- 2 generations backK031023 Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · Recalled
- 1 generation backK122997 23GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
- This deviceK151604 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK233653 Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga…Peregrine Surgical, LLC · 2024
- Descendant · cites it directly · 0 of its ownK182646 Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954307 | Gamp & Assoc. Disposable Endoocular Laser Probe | Gamp & Assoc. | 1995 | — |
| −3 | K024061 | Peregrine Straight Laser Probe, Model PD6000.00 | Peregrine Surgical, Ltd. | 2003 | — |
| −2 | K031023 | Peregrine Illuminating Laser Probe Model PD600.10 | Peregrine Surgical, Ltd. | 2003 | 1 |
| −1 | K122997 | 23GA Curved Illuminating Laser Probe | Peregrine Surgical, Ltd. | 2013 | — |
| 0 (this device) | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical, Ltd. | 2015 | — |
| +1 | K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga… | Peregrine Surgical, LLC | 2024 | — |
| +1 | K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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 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? (2)
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 |
|---|---|---|---|
| * | K980025 | Peregrine Tapered Diffusion ProbeSummary page 4…ate Devices Predicate Device 510(k) Product Code Company Name Name Peregrine Tapered K980025 MPA Peregrine Surgical, Diffusion Probe L… | 1998 |
| * | K122997 | 23GA Curved Illuminating Laser ProbeSummary page 4…MPA Peregrine Surgical, Diffusion Probe Ltd. 23 Gauge (ga) K122997 HQB, Peregrine Surgical, Curved Illuminating HQF, MPA L… | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K233653 (Peregrine Surgical, LLC, 2024) has gone furthest, with 0 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. 2015, this device’s year, is highlighted.
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?
Adjustable Chandelier Illuminator family of ophthalmic illuminators is for wide angle illumination during ophthalmic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151604: 23ga Chandelier Illuminator, 25ga Chandelier Illuminator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151604
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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