510(k) · Cleared
ClearedSpectra 9Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uzinmedicare Company · HGX Pump, Breast, Powered
Cleared on Mar 15, 2017 as substantially equivalent to K092783 (Enko, Ltd., 2009) after a 198-day review. Its family tree reaches back 4 generations to 1980. 32 later devices descend from it.
- Decided
- Mar 15, 2017
- Review
- 198 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K801862 (1980). 8 ancestors in all. 32 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 3 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 2 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 1 generation backK092783 DEBPEnko, Ltd. · 2009
- This deviceK162415 Spectra 9PlusUzinmedicare Company · 2017
- Descendant · cites it directly · 30 of its ownK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 21 of its ownK201903 Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd. · 2021
- Descendant · 3 generations on · 14 of its ownK222782 Wearable Breast Pump…Zhejiang Carebao Co., Ltd. · 2023
- Descendant · 4 generations on · 12 of its ownK232466 Electric Breast Pump, model: YM-8166Guangdong Youmeng Electrical Technology Co., Ltd. · 2024
- Descendant · 5 generations on · 11 of its ownK241322 Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 2024
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K163136Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017 · cites it directly30descendants
- K201903Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd. · 2021 · 2 generations on21descendants
- K222782Wearable Breast Pump…Zhejiang Carebao Co., Ltd. · 2023 · 3 generations on14descendants
- K232466Electric Breast Pump, model: YM-8166Guangdong Youmeng Electrical Technology Co., Ltd. · 2024 · 4 generations on12descendants
- K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 2024 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −3 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −2 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −1 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| 0 (this device) | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
| +1 | K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017 | — |
| +2 | K201903 | Electric breast pump (Models: RH-228 and RH-338) | Cixi Ruihong Electric Appliance Co., Ltd. | 2021 | — |
| +3 | K222782 | Wearable Breast Pump… | Zhejiang Carebao Co., Ltd. | 2023 | — |
| +4 | K232466 | Electric Breast Pump, model: YM-8166 | Guangdong Youmeng Electrical Technology Co., Ltd. | 2024 | — |
| +5 | K241322 | Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) | Joytech Healthcare Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K092783 | DEBPSummary page 4…160 Product Code: HGX (pump, breast, powered) Class: II PREDICATE DEVICE INFORMATION: Double Electric Breast Pump (K092783) The predicate device has not been subject to a design related recall. Page 1 of 4… | 2009 |
What descends from it? (32)
See all 322 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 37 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K163136 (Ningbo Youhe Electrical Appliance Technology Co., Ltd., 2017) has gone furthest, with 30 descendants of its own.
- 2 other devices also cite its predicate K092783.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Spectra 9Plus is a single user, powered breast pump intended to express and collect milk from the breasts of lactating women.
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/K162415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162415: Spectra 9Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162415
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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