510(k) · Cleared

Cleared

Servo Guard, Model 64 81 290 EH88E

K030071510(k) TraditionalCleared Apr 26, 2004474-day reviewClass II21 CFR 868.5260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Maquet, Inc. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Apr 26, 2004 as substantially equivalent to K871366 (Siemens Elema AB, 1987) and 1 other predicate after a 474-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided: Apr 26, 2004
Review: 474 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K871366 (1987). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK871366 Siemens Main Flow Bacteria FilterSiemens Elema AB · 1987
This deviceK030071 Servo Guard, Model 64 81 290 EH88EMaquet, Inc. · 2004
Descendant · cites it directly · 0 of its ownK182862 Servo GuardMaquet Critical Care AB · 2019

Most influential descendants

Showing 1 of 1 · See all

K182862Servo GuardMaquet Critical Care AB · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871366	Siemens Main Flow Bacteria Filter	Siemens Elema AB	1987	—
0 (this device)	K030071	Servo Guard, Model 64 81 290 EH88E	Maquet, Inc.	2004	—
+1	K182862	Servo Guard	Maquet Critical Care AB	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K030071, 1987–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CAH device

#1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K871366	Siemens Main Flow Bacteria Filter Summary page 1 …o which equivalence is being claimed 510(k) # Siemens Main Flow Bacteria Filter K871366 End expiratory filter, Model RT020 K002839 Device Description (for d…	Siemens Elema AB	1987	—
*	K002839	End Expiratory Filter, Model RT020 Summary page 1 …a Filter K871366 End expiratory filter, Model RT020 K002839 Device Description (for detailed description see Section F) The Servo Guard is an efficient bacterial and viral filter for appl…	Fisher & Paykel Healthcare, Ltd.	2001	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K182862	Servo Guard	Maquet Critical Care AB	2019	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K182862 (Maquet Critical Care AB, 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CAH devices

CAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAH

2in 2024

2007high 5 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAH

237in 2023

2007high 281 (2011) · low 111 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAH

1in 2025

2007high 6 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · CAH

77in 2025

2007high 98 (2014) · low 9 (2011)2025

MAUDE reports naming product code CAH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	32
2008	1	—	0	27
2009	4	111	0	18
2010	5	216	2	40
2011	3	281	0	9
2012	3	212	0	16
2013	1	—	1	47
2014	4	250	1	98
2015	2	—	0	51
2016	0	—	0	34
2017	1	—	1	29
2018	0	—	0	33
2019	2	—	0	30
2020	2	—	0	33
2021	2	—	0	56
2022	3	204	6 (6)	67
2023	3	237	0	40
2024	2	—	0	51
2025	0	—	1 (1)	77
2026	2	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030071 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030071: Servo Guard, Model 64 81 290 EH88E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030071

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026