PEDIATRIC ANESTHESIA BREATHING CIRCUITS— 510(k) K800499

Name: FDA 510(k) clearance K800499
Creator: U.S. Food and Drug Administration
Published: 1980-03-25

Substantially Equivalent

Airlife, Inc.

FDA 510(k) clearance K800499 for PEDIATRIC ANESTHESIA BREATHING CIRCUITS, Substantially Equivalent on 1980-03-25. Applicant: Airlife, Inc.. Device class: 1.

Clearance details

Applicant: Airlife, Inc.
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1980-03-04
Decision date: 1980-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT1995-09-19
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K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1995-05-22
K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS1995-05-22

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K834570 — VOLUME VENTILATOR CIRCUIT W/WATER TRAP1984-03-05
K834573 — AQUA TRAP1984-03-05
K834077 — SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN1983-12-12
K833196 — VOLUME VENTILATOR CIRCUIT-NEBULIZER1983-11-03
K833197 — TRACH SWIVE/CONNECTOR1983-10-28

Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.