510(k) Report

FDA applicant

Ls Scientific Inc. D.B.A. Kse Scientific

Durham, NC1 decision2017–20170 recalls

FDA records 1 decision for Ls Scientific Inc. D.B.A. Kse Scientific (Durham, NC) in 2017: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Ls Scientific Inc. D.B.A. Kse Scientific’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ls Scientific Inc. D.B.A. Kse Scientific by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ls Scientific Inc. D.B.A. Kse Scientific’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?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K170270Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineLs Scientific Inc. D.B.A. Kse Scientific · 2017

The one decision as Ls Scientific Inc. D.B.A. Kse Scientific →