# K854244: The Keeler All Pupil Indirect Ophthalmoscope

- Pathway: 510(k) (Traditional)
- Applicant: Keeler Instruments, Inc.
- Decided: Nov 12, 1985 after 22 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jan 8, 2008 · Not classified · Z-1132-2008: Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.

Source page: https://510kreport.com/device/K854244
Methodology: https://510kreport.com/methodology