510(k) · Cleared
ClearedSpectra Series Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uzinmedicare Co. · HGX Pump, Breast, Powered
Cleared on Aug 13, 2010 as substantially equivalent to K061013 (Playtex Products, Inc., 2006) and 2 other predicates after a 312-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Aug 13, 2010
- Review
- 312 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K875300 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK875300 Medela Breast-Pump LactinaMedela, Inc. · 1988 · Recalled
- 3 generations backK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · Recalled
- 2 generations backK022594 Playtex Breast PumpPlaytex Products, Inc. · 2002
- 1 generation backK061013 Playtex Embrace Petite Breast PumpPlaytex Products, Inc. · 2006 · Recalled
- This deviceK093145 Spectra Series Breast PumpUzinmedicare Co. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K875300 | Medela Breast-Pump Lactina | Medela, Inc. | 1988 | 3 |
| −3 | K973501 | Expresse and Premier Powered Breast Pumps | Ameda Medizintechnik AG | 1997 | 1 |
| −2 | K022594 | Playtex Breast Pump | Playtex Products, Inc. | 2002 | — |
| −1 | K061013 | Playtex Embrace Petite Breast Pump | Playtex Products, Inc. | 2006 | 1 |
| 0 (this device) | K093145 | Spectra Series Breast Pump | Uzinmedicare Co. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (3)
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 |
|---|---|---|---|
| * | K061013 | Playtex Embrace Petite Breast PumpSummary page 2…yeon, Yongin-Si, Kyeonggi-Do 449-885, Korea Tel.82-31-322-0132/Fax.82-3 1-322.4292 4.0Cassification of Device FDA has classified the predicate devices(K061013, K950750, K973501) as class 11, CFR § 884.5160. It is our understanding that the powered breast pump fall under… | 2006 |
| * | K950750 | Medelas Breast PumpSummary page 2…gin-Si, Kyeonggi-Do 449-885, Korea Tel.82-31-322-0132/Fax.82-3 1-322.4292 4.0Cassification of Device FDA has classified the predicate devices(K061013, K950750, K973501) as class 11, CFR § 884.5160. It is our understanding that the powered breast pump fall under the sa… | 1995 |
| * | K973501 | Expresse and Premier Powered Breast PumpsSummary page 2…yeonggi-Do 449-885, Korea Tel.82-31-322-0132/Fax.82-3 1-322.4292 4.0Cassification of Device FDA has classified the predicate devices(K061013, K950750, K973501) as class 11, CFR § 884.5160. It is our understanding that the powered breast pump fall under the same classi… | 1997 |
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 22 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 6 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. 2010, 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 electric breast pump is Single user product and intended to express breast milk from the breast of lactating woman.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093145: Spectra Series Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093145
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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