510(k) · Cleared
ClearedMini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A Cute Baby, Inc. · HGX Pump, Breast, Powered
Cleared on Mar 12, 2026 as substantially equivalent to K113315 (Acute Ideas Co., Ltd., 2012) after a 209-day review. Its family tree reaches back 5 generations to 1980.
- Decided
- Mar 12, 2026
- Review
- 209 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801862 (1980). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 4 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 3 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 2 generations backK092783 DEBPEnko, Ltd. · 2009
- 1 generation backK113315 Rumble TuffAcute Ideas Co., Ltd. · 2012
- This deviceK252583 Mini Moon electric breast pump (PA221); Moon Wave electric breast…A Cute Baby, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −4 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −3 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −2 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −1 | K113315 | Rumble Tuff | Acute Ideas Co., Ltd. | 2012 | — |
| 0 (this device) | K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K113315 | Rumble TuffSummary page 5…icate Device Manufacturer: Acute Ideas Co., Ltd. Device Name: Rumble Tuff Electric Breast Pump 510(k) Number: K113315 The predicate device has not been subject to a design-related recall. 4. Device Description PA220 – Moon Wave Electric… | 2012 |
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?
- The line of descent spans 46 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K113315.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HGX
34so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · HGX
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGX
69in 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 Moon Wave (PA220) and Mini Moon (PA221) Electric Breast Pump is a personal use, electrically powered device used to express milk from the breasts of lactating women. This device is not intended for hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252583: Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252583
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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