ANESTHESIA BREATHING CIRCUIT— 510(k) K900594

Name: FDA 510(k) clearance K900594
Creator: U.S. Food and Drug Administration
Published: 1990-03-15

Substantially Equivalent

Inhalation Plastics

FDA 510(k) clearance K900594 for ANESTHESIA BREATHING CIRCUIT, Substantially Equivalent on 1990-03-15. Applicant: Inhalation Plastics. Device class: 1.

Clearance details

Applicant: Inhalation Plastics
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1990-02-07
Decision date: 1990-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Recent devices under product code CAI

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K954480 — CONDENSATE COLLECTION KIT1995-12-29
K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT1995-09-19
K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS1995-09-19
K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1995-05-22
K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS1995-05-22

More clearances from Inhalation Plastics

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K945565 — SPIRO-FLEX1995-01-13
K914686 — THERMO-FLOW SET1992-04-15
K901315 — AEROMIST II NEBULIZER1990-09-10
K900990 — FILT-R-ALL BACTERIAL/VIRAL FILTER1990-04-19
K896832 — FILT-R-ALL BACTERIAL FILTER1990-01-22

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.