OXIMETRY INTERFACE KIT— 510(k) K111378

Name: FDA 510(k) clearance K111378
Creator: U.S. Food and Drug Administration
Published: 2011-10-04

Substantially Equivalent

Philips Respironics, Inc.

FDA 510(k) clearance K111378 for OXIMETRY INTERFACE KIT, Substantially Equivalent on 2011-10-04. Applicant: Philips Respironics, Inc.. Device class: 2.

Clearance details

Applicant: Philips Respironics, Inc.
Product code: Code MNS
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2011-05-17
Decision date: 2011-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

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 K111378

K-number listed on FDA's recall record

Z-1973-2021 — DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.Class I·Ongoing·Philips Respironics, Inc.·20210614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111378.

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