510(k) · Cleared
ClearedEvenflo Advanced Double Electric Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evenflo Feeding Incorporated · HGX Pump, Breast, Powered
Cleared on Jun 18, 2013 as substantially equivalent to K973501 (Ameda Medizintechnik AG, 1997) and 1 other predicate after a 55-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Jun 18, 2013
- Review
- 55 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K875300 (1988). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK875300 Medela Breast-Pump LactinaMedela, Inc. · 1988 · Recalled
- 1 generation backK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · Recalled
- This deviceK131153 Evenflo Advanced Double Electric Breast PumpEvenflo Feeding Incorporated · 2013
- Descendant · cites it directly · 0 of its ownK230481 Evenflo Premium Double Electric Breast Pump (Model 4018)Evenflo Feeding, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK150923 Breast PumpGuangzhou Jinxinbao Electronic Co., Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875300 | Medela Breast-Pump Lactina | Medela, Inc. | 1988 | 3 |
| −1 | K973501 | Expresse and Premier Powered Breast Pumps | Ameda Medizintechnik AG | 1997 | 1 |
| 0 (this device) | K131153 | Evenflo Advanced Double Electric Breast Pump | Evenflo Feeding Incorporated | 2013 | — |
| +1 | K230481 | Evenflo Premium Double Electric Breast Pump (Model 4018) | Evenflo Feeding, Inc. | 2023 | — |
| +1 | K150923 | Breast Pump | Guangzhou Jinxinbao Electronic Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K973501 | Expresse and Premier Powered Breast PumpsSummary page 1…Double Electric Breast Pump Common/Usual Name: Powered breast pump Classification Name: Powered breast pump " HGX - CFR 884.5160 Class 2 - OTC Predicate Devices: , -‘K973501 — Ameda — Purely Yours K 102600 — Evenflo — SimplyGo Device Description: The Evenflo Advanced Double Electric Breast Pump is a… | 1997 |
| * | K102600 | Simplygo Breast PumpSummary page 1…mon/Usual Name: Powered breast pump Classification Name: Powered breast pump " HGX - CFR 884.5160 Class 2 - OTC Predicate Devices: , -‘K973501 — Ameda — Purely Yours K 102600 — Evenflo — SimplyGo Device Description: The Evenflo Advanced Double Electric Breast Pump is an electrically powered breast pum… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K230481 (Evenflo Feeding, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K973501.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman’s breasts. This is for a single user.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131153: Evenflo Advanced Double 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/K131153
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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