510(k) Report

FDA applicant

Kiltex Corp.

Akron, OH1 decision1996–19962 recalls

FDA records 1 decision for Kiltex Corp. (Akron, OH) in 1996: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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 Kiltex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kiltex Corp. since 2007.

Recalls per year

2in 2017

2017: 2
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K961029Kiltex Probe CoverKiltex Corp. · 19961cites it

What has FDA decided for it lately?

  • K961029Kiltex Probe CoverKiltex Corp. · 19962 recalls

The one decision as Kiltex Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K961029ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged…Nov 22, 2017Class III
  • K961029ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1…Nov 22, 2017Class III