# K182862: Servo Guard

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Oct 21, 2019 after 375 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
Longest line of descent: 2 generations back to K871366 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030071: Servo Guard, Model 64 81 290 EH88E, Maquet, Inc. (2004) Summary page 4.

## Indications for use
The Servo Guard is a bacterial/viral filter for applications in respiratory care. The filter is intended to be used in patient circuits to reduce the spread of viruses and bacteria from patient to patient/personnel and to protect the patient circuits and ventilators from contamination. The filter shall only be used with the ventilators Servo-u, Servo-n, Servo-i and Servo-s.

Source page: https://510kreport.com/device/K182862
Methodology: https://510kreport.com/methodology