LOFLO C5 CO2 SENSOR— 510(k) K053174

Name: FDA 510(k) clearance K053174
Creator: U.S. Food and Drug Administration
Published: 2006-01-12

Substantially Equivalent

Respironics Novametrix, LLC

FDA 510(k) clearance K053174 for LOFLO C5 CO2 SENSOR, Substantially Equivalent on 2006-01-12. Applicant: Respironics Novametrix, LLC. Device class: 2.

Clearance details

Applicant: Respironics Novametrix, LLC
Product code: Code CCK
Device class: Class 2
Regulation: 21 CFR 868.1400
Advisory panel: Anesthesiology
Date received: 2005-11-14
Decision date: 2006-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCK

view all

K251641 — GF-310R Multigas Unit (GF-310R)2026-08-12
K261633 — VisuBreath2026-07-14
K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN)2026-05-01
K250148 — Medical Gas Analyzer (AG200)2025-08-28
K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)2025-06-10

More clearances from Respironics Novametrix, LLC

view all

K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST2011-06-02
K091459 — PHILIPS NM3 MONITOR, MODEL 79002009-07-28
K080652 — MERCURY VCO2 MODULE WITH CAPNOSTAT 52008-06-20

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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 →

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