510(k) · Cleared

Cleared

Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y Filter Packaged Alone

K945543510(k) TraditionalCleared Nov 29, 199415-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

Intersect Medical Products, Inc. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Nov 29, 1994 after a 15-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: Nov 29, 1994
Review: 15 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK945543 Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000…Intersect Medical Products, Inc. · 1994
Descendant · cites it directly · 1 of its ownK013256 BI-3M Needle-Free Injector SystemFelton International, Inc. · 2001
Descendant · 2 generations on · 0 of its ownK041280 Human Subcutaneous Injector, Model Hsi 500Felton International, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all

K013256BI-3M Needle-Free Injector SystemFelton International, Inc. · 2001 · cites it directly1descendant
K041280Human Subcutaneous Injector, Model Hsi 500Felton International, Inc. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945543	Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y…	Intersect Medical Products, Inc.	1994	—
+1	K013256	BI-3M Needle-Free Injector System	Felton International, Inc.	2001	—
+2	K041280	Human Subcutaneous Injector, Model Hsi 500	Felton International, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	1	0

FIG. 1 — Lineage of K945543, 1994–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K013256	BI-3M Needle-Free Injector System	Felton International, Inc.	2001	1

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?

Of its descendants, K013256 (Felton International, Inc., 2001) has gone furthest, with 1 descendant 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	—

https://510kreport.com/device/K945543 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945543: Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y Filter Packaged Alone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945543

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026