CHILD SIZE - FILTER FLEX (TM)— 510(k) K893030

Name: FDA 510(k) clearance K893030
Creator: U.S. Food and Drug Administration
Published: 1989-09-18

Substantially Equivalent

Life Design Systems, Inc.

FDA 510(k) clearance K893030 for CHILD SIZE - FILTER FLEX (TM), Substantially Equivalent on 1989-09-18. Applicant: Life Design Systems, Inc.. Device class: 2.

Clearance details

Applicant: Life Design Systems, Inc.
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 1989-04-24
Decision date: 1989-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, WI, 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 Life Design Systems, Inc.

view all

K913714 — MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)1992-12-01
K885313 — HUMIDI-FLEX TM1989-10-11
K892862 — FLEX-CUP PERCUSSOR1989-05-25
K892221 — PULMONARY RESUSCITATOR, MODIFICATION1989-05-18
K890011 — OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING1989-03-20

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.