# K964405: Mbi Illuminated Retinal Pick

- Pathway: 510(k) (Traditional)
- Applicant: M.B. Industries, Inc.
- Decided: May 13, 1997 after 190 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: 2 generations back to K854587 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961036: Mbi Fiberoptic Endo-Illuminator, M.B. Industries, Inc. (1996) Summary page 1.
- K875195: Ophthalmic Light Pipe Pick, Trek Medical Products, Inc. (1988) Summary page 1.
- (no number) Hand held surgical instrument: named in the summary without a submission number

## Indications for use
illumination of the operating field and/or the use of a manipulating tool during ophthalmic surgery

Source page: https://510kreport.com/device/K964405
Methodology: https://510kreport.com/methodology