KC 300 SURGICAL MASK— 510(k) K131879

Name: FDA 510(k) clearance K131879
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K131879 for KC 300 SURGICAL MASK, Substantially Equivalent on 2013-12-20. Applicant: Kimberly-Clark Corp.. Device class: 2.

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code FXX
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2013-06-24
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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K131254 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE2013-08-20
K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING2012-12-19

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K131879

K-number listed on FDA's recall record

Z-1059-2023 — FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147Class III·Ongoing·Owens & Minor Distribution, Inc.·20230103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131879.

Data sourced from openFDA. This site is unofficial and independent of the FDA.