# K032087: Keeler Wide Angle Ophthalmoscope Model 1130-P-5004

- Pathway: 510(k) (Traditional)
- Applicant: Keeler Instruments, Inc.
- Decided: Nov 26, 2003 after 142 days
- Product code: HLJ (Ophthalmoscope, Battery-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Welch Allyn 11800 Ophthalmoscope: named in the summary without a submission number

## Indications for use
The Keeler Wide Angle Ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. It has the same operating principles and intended use as many competitive ophthalmoscopes already in commercial distribution. The device is intended to be used by trained personnel within a medical or school environment.

Source page: https://510kreport.com/device/K032087
Methodology: https://510kreport.com/methodology