510(k) · Cleared
ClearedEvolve Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hygeia II Medical Group, Inc. · HGX Pump, Breast, Powered
Cleared on Oct 18, 2019 as substantially equivalent to K081932 (Hygeia Medical, Inc., 2009) after a 234-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Oct 18, 2019
- Review
- 234 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K875300 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK875300 Medela Breast-Pump LactinaMedela, Inc. · 1988 · Recalled
- 2 generations backK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · Recalled
- 1 generation backK081932 Endeare Breast PumpHygeia Medical, Inc. · 2009
- This deviceK190465 Evolve Breast PumpHygeia II Medical Group, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK200406 Evolve Breast PumpHygeia II Medical Group, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200406Evolve Breast PumpHygeia II Medical Group, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875300 | Medela Breast-Pump Lactina | Medela, Inc. | 1988 | 3 |
| −2 | K973501 | Expresse and Premier Powered Breast Pumps | Ameda Medizintechnik AG | 1997 | 1 |
| −1 | K081932 | Endeare Breast Pump | Hygeia Medical, Inc. | 2009 | — |
| 0 (this device) | K190465 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | 2019 | — |
| +1 | K200406 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K081932 | Endeare Breast PumpSummary page 4…n: 21 CFR 884.5160 Device Classification: Class II Product Code: HGX Product Code Name: Pump, Breast, Powered Predicate Device Information Hygeia EnDeare Breast Pump, K081932 This predicate has not been subject to a design-related recall.… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200406 | Evolve Breast Pump | 2020 | 0 |
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 31 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K200406 (Hygeia II Medical Group, Inc., 2020) has gone furthest, with 0 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. 2019, 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 Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190465: Evolve Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190465
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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