# K961036: Mbi Fiberoptic Endo-Illuminator

- Pathway: 510(k) (Traditional)
- Applicant: M.B. Industries, Inc.
- Decided: Jul 15, 1996 after 123 days
- Product code: MPA (Endoilluminator)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854587 (1986). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854587: Storz MVS Disposable Fiberoptic Lightpipe, Storz Instrument Co. (1986) Summary page 1.

## Most influential descendants
- K964553: Mbi CO-Axial Illuminated Retinal Pick (1997), 0 descendants of its own
- K964405: Mbi Illuminated Retinal Pick (1997), 0 descendants of its own

## Indications for use
illumination of the operating field during ophthalmic surgery

Source page: https://510kreport.com/device/K961036
Methodology: https://510kreport.com/methodology