FDA applicant

Kolplast CI SA

Itupeva- Sp, BR2 decisions2011–20170 recalls

FDA records 2 decisions for Kolplast CI SA (Itupeva- Sp, BR) from 2011 to 2017: 2 510(k) clearances. Most are in product codes HHT (Spatula, Cervical, Cytological) and HIB (Speculum, Vaginal, Nonmetal). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kolplast CI Ltda”.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Kolplast CI SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Kolplast CI SA by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kolplast CI SA’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 “Kolplast”

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

Kolplast Comercial E Industrial Ltda 1

Kolplast CI SA

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Kolplast”