510(k) · Cleared
ClearedPerifit Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X6 Innovations · HGX Pump, Breast, Powered
Cleared on Jan 26, 2024 as substantially equivalent to K210936 (Chiaro Technology Limited, 2021) after a 220-day review. Its family tree reaches back 8 generations to 1980. 2 later devices descend from it.
- Decided
- Jan 26, 2024
- Review
- 220 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. 2 later devices descend from it, 2 citing it directly.
- 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 backK181863 Elvie PumpChiaro Technology Limited · 2018
- 1 generation backK210936 Elvie StrideChiaro Technology Limited · 2021
- This deviceK231785 Perifit PumpX6 Innovations · 2024
- Descendant · cites it directly · 0 of its ownK251977 electric breast pump (FZ-P8); electric breast pump (YH-P8); electric…Ningbo Youhe Electrical Appliance Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK250207 eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10…Anker Innovations Limited · 2025
Most influential descendants
Showing 2 of 2 · See all- K251977electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)Ningbo Youhe Electrical Appliance Technology Co., Ltd. · 2025 · cites it directly0descendants
- K250207eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)Anker Innovations Limited · 2025 · cites it directly0descendants
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 | K181863 | Elvie Pump | Chiaro Technology Limited | 2018 | — |
| −1 | K210936 | Elvie Stride | Chiaro Technology Limited | 2021 | — |
| 0 (this device) | K231785 | Perifit Pump | X6 Innovations | 2024 | — |
| +1 | K251977 | electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast… | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025 | — |
| +1 | K250207 | eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) | Anker Innovations Limited | 2025 | — |
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 |
|---|---|---|
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K210936 | Elvie StrideSummary page 5…ed breast pump Regulation Number: 21 CFR 884.5160 Regulatory Class: Class II Product Code: HGX (Pump, Breast, Powered) III. Predicate Device: Elvie Stride (K210936), Chiaro Technology Limited, 2nd Floor 63-66 Hatton Garden, London, GB EC1N 8LE The predicate device has not been subject… | 2021 |
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 44 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K251977 (Ningbo Youhe Electrical Appliance Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K210936.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Perifit Pump is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231785: Perifit Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231785
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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