# K990949: Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas Monitoring Port

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: Jun 15, 1999 after 85 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.
16 later devices descend from it; 2 cite it directly.
6 of 17 devices 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.

## Most influential descendants
- K081837: Avea Ventilator (2008), 13 descendants of its own
- K092847: 840 Ventilator System with Expanded Neomode Option (2010), 11 descendants of its own
- K151252: Puritan Bennett 840 Series Ventilator System (2016), 7 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own

## Indications for use
1844 & 1844-F: For usc at the equipment connection. Desigred to reduce bacterial/viral transmission to and from patient, equipment and environmant. CAYXTIONS: When used in the sxhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient, 1841 & 1841-T: For usc at the patient contection. Designed to reduce bacterial/viral transmission and 1o reduce the loss of patient hoat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious sceretions; Do not use this preduct in conjunction with other humidification sourees. 1844, 1844-P, 1841, 1841-T: ISO connections: When essembling any connections use a push and twist action (o 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 & water bath bumidifier; Do not us¢ this product between the patient and a source of nebulized drugs; When nebulized drugg are administered, resistance ghould be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in usc; Replace every 24 hours or more frequently if visible deterioration i 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/K990949
Methodology: https://510kreport.com/methodology