510(k) · Cleared
ClearedSimplygo Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evenflo Company, Inc. · HGX Pump, Breast, Powered
Cleared on Dec 22, 2010 after a 103-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Dec 22, 2010
- Review
- 103 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK102600 Simplygo Breast PumpEvenflo Company, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK131153 Evenflo Advanced Double Electric Breast PumpEvenflo Feeding Incorporated · 2013
- Descendant · 2 generations on · 0 of its ownK230481 Evenflo Premium Double Electric Breast Pump (Model 4018)Evenflo Feeding, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK150923 Breast PumpGuangzhou Jinxinbao Electronic Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K131153Evenflo Advanced Double Electric Breast PumpEvenflo Feeding Incorporated · 2013 · cites it directly2descendants
- K230481Evenflo Premium Double Electric Breast Pump (Model 4018)Evenflo Feeding, Inc. · 2023 · 2 generations on0descendants
- K150923Breast PumpGuangzhou Jinxinbao Electronic Co., Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102600 | Simplygo Breast Pump | Evenflo Company, Inc. | 2010 | — |
| +1 | K131153 | Evenflo Advanced Double Electric Breast Pump | Evenflo Feeding Incorporated | 2013 | — |
| +2 | K230481 | Evenflo Premium Double Electric Breast Pump (Model 4018) | Evenflo Feeding, Inc. | 2023 | — |
| +2 | K150923 | Breast Pump | Guangzhou Jinxinbao Electronic Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131153 | Evenflo Advanced Double Electric Breast Pump | 2013 | 2 |
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, K131153 (Evenflo Feeding Incorporated, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 SimplyGoiM Breast Pump Kit is an electrically operated suction device used to express and collect milk from the breast(s) of lactating women.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K102600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102600: Simplygo 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/K102600
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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