510(k) · Cleared
ClearedElvie Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiaro Technology Limited · HGX Pump, Breast, Powered
Cleared on Oct 10, 2018 as substantially equivalent to K150499 (Medela AG, 2015) after a 90-day review. Its family tree reaches back 6 generations to 1980. 10 later devices descend from it.
- Decided
- Oct 10, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K801862 (1980). 10 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 5 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 4 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 3 generations backK092783 DEBPEnko, Ltd. · 2009
- 2 generations backK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- 1 generation backK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- This deviceK181863 Elvie PumpChiaro Technology Limited · 2018
- Descendant · cites it directly · 5 of its ownK210936 Elvie StrideChiaro Technology Limited · 2021
- Descendant · 2 generations on · 2 of its ownK231785 Perifit PumpX6 Innovations · 2024
- Descendant · cites it directly · 2 of its ownK202037 imani i2Imani Co. · 2021
- Descendant · 2 generations on · 1 of its ownK220926 Spectra WearableUzinmedicare Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK250208 SPECTRA Wearable 2Uzinmedicare Co., Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K210936Elvie StrideChiaro Technology Limited · 2021 · cites it directly5descendants
- K231785Perifit PumpX6 Innovations · 2024 · 2 generations on2descendants
- K202037imani i2Imani Co. · 2021 · cites it directly2descendants
- K220926Spectra WearableUzinmedicare Co., Ltd. · 2022 · 2 generations on1descendant
- K250208SPECTRA Wearable 2Uzinmedicare Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −5 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −4 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −3 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −2 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| −1 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| 0 (this device) | K181863 | Elvie Pump | Chiaro Technology Limited | 2018 | — |
| +1 | K210936 | Elvie Stride | Chiaro Technology Limited | 2021 | — |
| +2 | K231785 | Perifit Pump | X6 Innovations | 2024 | — |
| +1 | K202037 | imani i2 | Imani Co. | 2021 | — |
| +2 | K220926 | Spectra Wearable | Uzinmedicare Co., Ltd. | 2022 | — |
| +3 | K250208 | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantySummary page 4…n Number: 21 CFR 884.5160, Powered breast pump Regulatory Class: Class II Product Code: HGX (pump, breast, powered) Predicate Device(s): Medela Freestyle (K150499) The predicate device has not been subject to a design related recall. Device Description: The Elvie Pum… | 2015 |
What descends from it? (10)
3 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 38 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K210936 (Chiaro Technology Limited, 2021) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K150499.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Elvie Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.
The Elvie Pump is intended 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/K181863 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181863: Elvie Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181863
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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