# K030071: Servo Guard, Model 64 81 290 EH88E

- Pathway: 510(k) (Traditional)
- Applicant: Maquet, Inc.
- Decided: Apr 26, 2004 after 474 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: 1 generation back to K871366 (1987). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871366: Siemens Main Flow Bacteria Filter, Siemens Elema AB (1987) Summary page 1.
- K002839: End Expiratory Filter, Model RT020, Fisher & Paykel Healthcare, Ltd. (2001) Summary page 1.

## Most influential descendants
- K182862: Servo Guard (2019), 0 descendants of its own

## Indications for use
The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment. The device is intended for adult, pediatric and infant populations. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K030071
Methodology: https://510kreport.com/methodology