510(k) · Cleared
ClearedAViTA Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avita Corporation · HGX Pump, Breast, Powered
Cleared on Jun 11, 2026 as substantially equivalent to K201381 (Philips Consumer Lifestyle - Innovation Site Eindhoven, 2020) after a 510-day review. Its family tree reaches back 8 generations to 1980.
- Decided
- Jun 11, 2026
- Review
- 510 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K801862 (1980). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 7 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 6 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 5 generations backK092783 DEBPEnko, Ltd. · 2009
- 4 generations backK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- 3 generations backK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- 2 generations backK161532 Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven · 2016
- 1 generation backK201381 Philips Avent Single/Double electric breast pump AdvancedPhilips Consumer Lifestyle - Innovation Site Eindhoven · 2020
- This deviceK250129 AViTA Breast PumpAvita Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −7 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −6 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −5 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −4 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| −3 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| −2 | K161532 | Philips Avent Comfort Single/Twin Electric Breast Pump | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2016 | — |
| −1 | K201381 | Philips Avent Single/Double electric breast pump Advanced | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2020 | — |
| 0 (this device) | K250129 | AViTA Breast Pump | Avita Corporation | 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 |
|---|---|---|---|
| * | K201381 | Philips Avent Single/Double electric breast pump AdvancedSummary page 5…d) Classification Panel Obstetrics/Gynecology Device Class: Class II 4. Predicate Device Information 510(k) Number: K201381 Predicate Trade Name: Philips Avent single/double electric breast pump Advanced… | 2020 |
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 6 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K201381.
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 AViTA Breast Pump is intended to express and collect milk from the breasts of lactating women, and to alleviate engorgement of the breast. The device is intended for a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250129: AViTA 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/K250129
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026