FDA applicant

Summit Industries, Inc.

Chicago, IL8 decisions1985–20184 recalls

FDA records 8 decisions for Summit Industries, Inc. (Chicago, IL) from 1985 to 2018: 8 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and IXW (Processor, Radiographic-Film, Automatic). Its devices cite 2 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Summit Industries, LLC”.

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

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

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

FDA decisions per year

1in 2018

2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Summit Industries, 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 “Summit”

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

Summit Medical, Inc. 14 Summit World Trade Corp. 10 Summit Doppler Systems, Inc. 7 Summit Nuclear 6 Summit Technology, Inc. 5 Summit Glove, Inc. 5 Summit Medical Products, Inc. 4 Summit Optics, Inc. 2 Summit Spine 2 Summit Medventures 2 Summit Durable Medical Equipment, Inc. 1 Summit TO Sea 1

Summit Industries, 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 “Summit”