HUMIDIFIER FILTER— 510(k) K780535

Name: FDA 510(k) clearance K780535
Creator: U.S. Food and Drug Administration
Published: 1978-04-27

Substantially Equivalent

Hudson Oxygen Therapy Sales Co.

FDA 510(k) clearance K780535 for HUMIDIFIER FILTER, Substantially Equivalent on 1978-04-27. Applicant: Hudson Oxygen Therapy Sales Co.. Device class: 2.

Clearance details

Applicant: Hudson Oxygen Therapy Sales Co.
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 1978-04-03
Decision date: 1978-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAH

view all

K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled2026-05-15
K251583 — Ambu® Virobac II® Exhalation Filter2026-04-30
K241339 — Besmed Bacterial Filter and HMEF2024-11-14
K222917 — Breathing circuit bacterial/viral filter2024-02-15
K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)2023-09-16

More clearances from Hudson Oxygen Therapy Sales Co.

view all

K902062 — PEEP VALVE1990-09-04
K900783 — MDI ADAPTOR1990-07-18
K900470 — IN-THE NEBULIZER1990-05-18
K895589 — MANUAL RESUSCITATOR1990-03-30
K896136 — INFANT C.P.A.P. MONITOR1990-01-09

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.