# K032322: Clear-Therm Micro Hme, Model 1441

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: May 13, 2004 after 290 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
The Intersurgical Clear-Therm Micro Filter is for use at the patient connection. It is designed to reduce bacterial/viral transmissions between the patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the hospital and home. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K032322
Methodology: https://510kreport.com/methodology