510(k) · Cleared
ClearedMbi Illuminated Retinal Pick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.B. Industries, Inc. · MPA Endoilluminator
Cleared on May 13, 1997 as substantially equivalent to K961036 (M.B. Industries, Inc., 1996) and 1 other predicate after a 190-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- May 13, 1997
- Review
- 190 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K854587 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854587 | Storz MVS Disposable Fiberoptic Lightpipe | Storz Instrument Co. | 1986 | — |
| −1 | K961036 | Mbi Fiberoptic Endo-Illuminator | M.B. Industries, Inc. | 1996 | — |
| 0 (this device) | K964405 | Mbi Illuminated Retinal Pick | M.B. Industries, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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? (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 |
|---|---|---|---|
| * | K961036 | Mbi Fiberoptic Endo-IlluminatorSummary page 1…ed ad Illuminator, Fiberoptic, Surgical Field - HBI Reg 878.4580. There are no standards applying to it. The device is equivalent to the MBI Fiberoptic Endo-illuminator K961036 combined with a hand held surgical instrument. It is virtually identical to the Trek 9801 Light Pipe Pick K875195. The MBI device… | 1996 |
| * | K875195 | Ophthalmic Light Pipe PickSummary page 1…ce is equivalent to the MBI Fiberoptic Endo-illuminator K961036 combined with a hand held surgical instrument. It is virtually identical to the Trek 9801 Light Pipe Pick K875195. The MBI device has the same intended use, illumination of the operating field and/or the use of a manipulating tool during ophth… | 1988 |
| * | — | Hand held surgical instrument Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 10.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K961036.
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?
illumination of the operating field and/or the use of a manipulating tool 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/K964405 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964405: Mbi Illuminated Retinal Pick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964405
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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