# K024270: Clear-Therm 3 Hmef, Clear-Therm 3 with Superset Catheter Mount,Clear-Therm with Flexible Catheter Mount,Clear-Guard 3 F3

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: Jun 24, 2003 after 183 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
1544, 1544-T & 1544-F: For use at the equipment or patient connection. Designed to reduce bacteriaVvira1 transmission to and from patient, equipment and environment. CAUTIOSS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient; 1541, 1541-T 6: 1541-F: For use at the patient connection. Designed to reduce bacterial'vinl transmission and to reduce the loss of patient heat and humidity. CALTIOSS: l h i s product is not suitable for patients with thick or copious secretions; DO not use this product in conjunction with other humidification sources. 1544, 1544-T, 1544-F, 1541, 1541-T, 1541-F: I S 0 connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier; Do not use this product between the patient and a source of nebulized drugs; When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure; Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K024270
Methodology: https://510kreport.com/methodology