510(k) · Cleared
ClearedPeregrine Fiber Optic Multi-Function Manipulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peregrine Surgical, Ltd. · MPA Endoilluminator
Cleared on May 19, 1998 after a 78-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- May 19, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK980797 Peregrine Fiber Optic Multi-Function ManipulatorPeregrine Surgical, Ltd. · 1998
- Descendant · cites it directly · 11 of its ownK024061 Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003
- Descendant · 2 generations on · 6 of its ownK031023 Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · Recalled
- Descendant · 3 generations on · 4 of its ownK122997 23GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
- Descendant · 4 generations on · 2 of its ownK151604 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K024061Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003 · cites it directly11descendants
- K031023Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · 2 generations on6descendants
- K12299723GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013 · 3 generations on4descendants
- K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015 · 4 generations on2descendants
- K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980797 | Peregrine Fiber Optic Multi-Function Manipulator | Peregrine Surgical, Ltd. | 1998 | — |
| +1 | 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 |
| +3 | K122997 | 23GA Curved Illuminating Laser Probe | Peregrine Surgical, Ltd. | 2013 | — |
| +4 | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical, Ltd. | 2015 | — |
| +2 | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | — | Grieshaber & Co. 3-Function Manipulator Named without a submission number |
What descends from it? (12)
See all 122 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, K024061 (Peregrine Surgical, Ltd., 2003) has gone furthest, with 11 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 lllumination, coagulation, irrigation/aspiration, and tissue manipulation
during ophthalmic 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/K980797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980797: Peregrine Fiber Optic Multi-Function Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980797
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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