510(k) · Cleared
ClearedSPECTRA Wearable 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uzinmedicare Co., Ltd. · HGX Pump, Breast, Powered
Cleared on Apr 6, 2026 as substantially equivalent to K220926 (Uzinmedicare Co., Ltd., 2022) after a 437-day review. Its family tree reaches back 9 generations to 1980.
- Decided
- Apr 6, 2026
- Review
- 437 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K801862 (1980). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 5 generations between
- 3 generations backK181863 Elvie PumpChiaro Technology Limited · 2018
- 2 generations backK202037 imani i2Imani Co. · 2021
- 1 generation backK220926 Spectra WearableUzinmedicare Co., Ltd. · 2022
- This deviceK250208 SPECTRA Wearable 2Uzinmedicare Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 8 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 7 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 6 generations backK092783 DEBPEnko, Ltd. · 2009
- 5 generations backK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- 4 generations backK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- 3 generations backK181863 Elvie PumpChiaro Technology Limited · 2018
- 2 generations backK202037 imani i2Imani Co. · 2021
- 1 generation backK220926 Spectra WearableUzinmedicare Co., Ltd. · 2022
- This deviceK250208 SPECTRA Wearable 2Uzinmedicare Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −8 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −7 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −6 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −5 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| −4 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| −3 | K181863 | Elvie Pump | Chiaro Technology Limited | 2018 | — |
| −2 | K202037 | imani i2 | Imani Co. | 2021 | — |
| −1 | K220926 | Spectra Wearable | Uzinmedicare Co., Ltd. | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K220926 | Spectra WearableSummary page 5…gulatory Class: II 4. Predicate Device Information Device Name: SPECTRA Wearable 510(k) Number: K220926 Manufacturer: Uzinmedicare Co., Ltd. The predicate device has not been subject to a design-… | 2022 |
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 7 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 13 ancestors have a recall of any class.
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 SPECTRA Wearable 2 is a powered breast pump to be used by lactating women to stimulate, express and collect milk from their breasts. The SPECTRA Wearable 2 is intended for home use by a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250208 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250208: SPECTRA Wearable 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250208
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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