510(k) · Cleared
ClearedRumble Tuff Electric Breast Pump
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 Apr 17, 2020 as substantially equivalent to K113315 (Acute Ideas Co., Ltd., 2012) after a 30-day review. Its family tree reaches back 5 generations to 1980.
- Decided
- Apr 17, 2020
- Review
- 30 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 deviceK200712 Rumble Tuff Electric Breast PumpA Cute Baby, Inc. · 2020
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) | K200712 | Rumble Tuff Electric Breast Pump | A Cute Baby, Inc. | 2020 | — |
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 4…Breast, Powered) Classification Panel: Obstetrics/Gynecology 3. Predicate Device Information: Predicate Device: Rumble Tuff Electric Breast Pump (K113315) The predicate device has not been subject to design-related reca… | 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 40 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. 2020, 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 Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating Women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200712: Rumble Tuff Electric 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/K200712
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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