# K983610: Clear-Guard Midi, Clear-Guard Midi W/Flextube, Clear-Therm Mini, Clear-Therm Mini W/Flextube, Models 1644,1644-T,1831,18

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: Apr 30, 1999 after 198 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1644 & 1644-T: For use at the equipment connection. Designed to reduce bacterial transmission to and from patient, equipment and environment. CAUTIONS: 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; 1831 & 1831-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions; Do not use this product in conjunction with other humidification sources. 1644, 1644-T, 1831, 1831-T: ISO 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/K983610
Methodology: https://510kreport.com/methodology