FDA applicant

Keeler Instruments, Inc.

Broomall, PA60 decisions1981–20191 recall

FDA records 60 decisions for Keeler Instruments, Inc. (Broomall, PA) from 1981 to 2019: 60 510(k) clearances. Most are in product codes HLI (Ophthalmoscope, Ac-Powered) and HKX (Tonometer, Ac-Powered). Its devices cite 6 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Keeler Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Keeler Instruments, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Keeler Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Keeler”

FDA records each applicant name separately; these may or may not be the same firm.

Keeler Limited 9 Keeler Optical Products, Ltd. 5

Keeler Instruments, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Keeler”