510(k) · Cleared

Cleared

Whisper Wear Breast Pump

K022140510(k) TraditionalCleared Sep 30, 200290-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

Whisper Wear · HGX Pump, Breast, Powered

Cleared on Sep 30, 2002 as substantially equivalent to K901344 (Medela, Inc., 1990) after a 90-day review. Its family tree reaches back 1 generation to 1990.

Decided: Sep 30, 2002
Review: 90 days
Class: Class II
Product code: HGX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K901344 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK901344 Medela Battery Operated Breast PumpMedela, Inc. · 1990
This deviceK022140 Whisper Wear Breast PumpWhisper Wear · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901344	Medela Battery Operated Breast Pump	Medela, Inc.	1990	—
0 (this device)	K022140	Whisper Wear Breast Pump	Whisper Wear	2002	—

FIG. 1 — Lineage of K022140, 1990–2002Source: 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 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? (1)

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
*	K901344	Medela Battery Operated Breast Pump Summary page 1 …is substantially equivalent to the Medela Mini Electric’ Breastpump, which is legally marketed and distributed by Mcdela, Inc. pursuant to 5 10(k) K901344. Device Description The Whisper Wear Breast Pump is a self-contained, battery-operated device that is won1…	Medela, Inc.	1990	—

Also cleared against K901344: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
3 other devices also cite its predicate K901344.

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	—

What is it indicated for?

The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022140 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022140: Whisper Wear Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022140

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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