510(k) · Cleared

Cleared

Egnell Elite

K950531510(k) TraditionalCleared Sep 22, 1995227-day reviewClass II21 CFR 884.5160

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

Hollister, Inc. · HGX Pump, Breast, Powered

Cleared on Sep 22, 1995 after a 227-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 186 later devices descend from it.

Decided: Sep 22, 1995
Review: 227 days
Class: Class II
Product code: HGX
Recalls: None
Predicates: 0

186 later devices descend from it, 5 citing it directly.

This deviceK950531 Egnell EliteHollister, Inc. · 1995
Descendant · cites it directly · 148 of its ownK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · Recalled
Descendant · cites it directly · 139 of its ownK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
Descendant · 2 generations on · 105 of its ownK053052 Medela Swing Breast PumpMedela AG · 2006
Descendant · 2 generations on · 100 of its ownK092783 DEBPEnko, Ltd. · 2009
Descendant · 3 generations on · 63 of its ownK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012

Showing 5 of 186 descendants. See all descendants

Descendants cleared per year

1997high 31 (2026) · low 0 (1998)2026

Most influential descendants

Showing 5 of 186 · See all

K973501Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · cites it directly148descendants
K020518Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · cites it directly139descendants
K053052Medela Swing Breast PumpMedela AG · 2006 · 2 generations on105descendants
K092783DEBPEnko, Ltd. · 2009 · 2 generations on100descendants
K122474Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012 · 3 generations on63descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K950531	Egnell Elite	Hollister, Inc.	1995	—
+1	K973501	Expresse and Premier Powered Breast Pumps	Ameda Medizintechnik AG	1997	1
+1	K020518	Medela Symphony Breast Pump, Model 024	Medela, Inc.	2002	3
+2	K053052	Medela Swing Breast Pump	Medela AG	2006	—
+2	K092783	DEBP	Enko, Ltd.	2009	—
+3	K122474	Lansinoh Powered Electric Breast Pump	Lansinoh Laboratories Saglik Gerecleri Tasarim San	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2002	2	0
2003	2	0
2004	1	0
2005	3	0
2006	2	0
2009	2	0
2010	5	0
2011	2	0
2012	6	0
2013	3	0
2014	3	0
2015	9	0
2016	7	0
2017	8	0
2018	5	0
2019	7	0
2020	9	0
2021	12	0
2022	14	0
2023	12	0
2024	15	0
2025	24	0
2026	31	0

FIG. 1 — Lineage of K950531, 1995–2026Source: 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 HGX? 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 HGX device

#1 K212180 Wearable Breast Pump (Model S12)score 34.9 · 8 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?

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

What descends from it? (186)

See all 186

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K973501	Expresse and Premier Powered Breast Pumps	Ameda Medizintechnik AG	1997	148
K020518	Medela Symphony Breast Pump, Model 024	Medela, Inc.	2002	139
K022594	Playtex Breast Pump	Playtex Products, Inc.	2002	3
K100435	Ameda Platinum Breast Pump	Evenflo Company, Inc.	2010	1
K061013	Playtex Embrace Petite Breast Pump	Playtex Products, Inc.	2006	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, K973501 (Ameda Medizintechnik AG, 1997) has gone furthest, with 148 descendants of its own.

How does its category compare?

All HGX devices

HGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HGX

34so far in 2026, the most since 2007

2007high 34 (2026) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGX

122in 2025

2007high 240 (2021) · low 103 (2010)2026

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

Recalls per year · HGX

1in 2017

2007high 5 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HGX

69in 2025

2007high 1,036 (2014) · low 0 (2009)2025

MAUDE reports naming product code HGX, 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	1	—	0	2
2008	2	—	0	2
2009	4	121	0	0
2010	7	103	5	88
2011	2	—	1	240
2012	6	180	0	685
2013	4	131	0	837
2014	3	120	0	1,036
2015	9	141	0	496
2016	7	121	0	373
2017	8	159	1	437
2018	6	136	0	291
2019	7	158	0	168
2020	9	128	0	168
2021	12	240	0	119
2022	15	190	0	154
2023	15	167	0	200
2024	19	168	0	118
2025	26	122	0	69
2026	34	142	0	—

https://510kreport.com/device/K950531 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950531: Egnell Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950531

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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