510(k) · Cleared
ClearedDEBP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enko, Ltd. · HGX Pump, Breast, Powered
Cleared on Oct 22, 2009 as substantially equivalent to K053052 (Medela AG, 2006) and 1 other predicate after a 42-day review. Its family tree reaches back 3 generations to 1980. 100 later devices descend from it.
- Decided
- Oct 22, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801862 (1980). 7 ancestors in all. 100 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 2 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 1 generation backK053052 Medela Swing Breast PumpMedela AG · 2006
- This deviceK092783 DEBPEnko, Ltd. · 2009
- Descendant · cites it directly · 63 of its ownK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- Descendant · 2 generations on · 55 of its ownK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- Descendant · cites it directly · 32 of its ownK162415 Spectra 9PlusUzinmedicare Company · 2017
- Descendant · 2 generations on · 30 of its ownK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
- Descendant · 3 generations on · 28 of its ownK161266 Athena Breast PumpExploramed Nc7, Inc. · 2016
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K122474Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012 · cites it directly63descendants
- K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantyMedela AG · 2015 · 2 generations on55descendants
- K162415Spectra 9PlusUzinmedicare Company · 2017 · cites it directly32descendants
- K163136Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017 · 2 generations on30descendants
- K161266Athena Breast PumpExploramed Nc7, Inc. · 2016 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −2 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −1 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| 0 (this device) | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| +1 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| +2 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| +1 | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
| +2 | K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017 | — |
| +3 | K161266 | Athena Breast Pump | Exploramed Nc7, Inc. | 2016 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 19 | 0 |
| 2026 | 24 | 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 |
|---|---|---|---|
| * | K053052 | Medela Swing Breast PumpSummary page 1…on Name: Powered Breast Pump Regulatory Class: Class II Product Codes: HGX Predicate Device(s): Medela swing Breastpump, By Medela Inc. (K053052) & Hollister Inc. Expresse and Premier Powered Breast Pump (Lactaline Personal) (K973501) Device Description: The Double Electr… | 2006 |
| * | K973501 | Expresse and Premier Powered Breast PumpsSummary page 1…HGX Predicate Device(s): Medela swing Breastpump, By Medela Inc. (K053052) & Hollister Inc. Expresse and Premier Powered Breast Pump (Lactaline Personal) (K973501) Device Description: The Double Electric Breast Pump (DEBP) is a powered breast pump. The pumping can be performed on one breas… | 1997 |
What descends from it? (100)
See all 1003 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 29 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K122474 (Lansinoh Laboratories Saglik Gerecleri Tasarim San, 2012) has gone furthest, with 63 descendants of its own.
- 4 other devices also cite its predicate K053052.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 DEBP is intended to express and collect the mother's milk of a nursing woman for
the purpose of feeding the collected milk to a baby.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092783: DEBP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092783
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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