510(k) · Cleared
ClearedSpectra S1Plus and Spectra S2 Plus
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 Apr 15, 2016 as substantially equivalent to K051926 (Limerick, Inc., 2005) after a 416-day review. Its family tree reaches back 4 generations to 1985. 24 later devices descend from it.
- Decided
- Apr 15, 2016
- Review
- 416 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K850705 (1985). 7 ancestors in all. 24 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK850705 The White River Porta-Elec-Breast PumpNatural Technologies, Inc. · 1985
- 3 generations backK971543 Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997
- 2 generations backK012275 PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002
- 1 generation backK051926 Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005
- This deviceK150476 Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016
- Descendant · cites it directly · 7 of its ownK181784 Spectra S3 PlusUzinmedicare Co. · 2018
- Descendant · cites it directly · 6 of its ownK180075 MINUET LCD, MINUET LCD ecoUnimom.Co · 2018
- Descendant · 2 generations on · 5 of its ownK190810 OPERA, OPERA ecoUnimom.Co · 2019
- Descendant · cites it directly · 4 of its ownK162870 CIMLRE F1 and CIMILRE S3Cimilre Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK201152 Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K181784Spectra S3 PlusUzinmedicare Co. · 2018 · cites it directly7descendants
- K180075MINUET LCD, MINUET LCD ecoUnimom.Co · 2018 · cites it directly6descendants
- K190810OPERA, OPERA ecoUnimom.Co · 2019 · 2 generations on5descendants
- K162870CIMLRE F1 and CIMILRE S3Cimilre Co., Ltd. · 2017 · cites it directly4descendants
- K201152Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850705 | The White River Porta-Elec-Breast Pump | Natural Technologies, Inc. | 1985 | — |
| −3 | K971543 | Luxmatic 12-15 Isc Portable Electric Breast Pump | Kaweco GmbH | 1997 | — |
| −2 | K012275 | PJ.S Comfort Portable Electric Breast Pump | Limerick, Inc. | 2002 | — |
| −1 | K051926 | Limerick PJ'S Comfort JR Portable Electric Breast Pump | Limerick, Inc. | 2005 | — |
| 0 (this device) | K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016 | — |
| +1 | K181784 | Spectra S3 Plus | Uzinmedicare Co. | 2018 | — |
| +1 | K180075 | MINUET LCD, MINUET LCD eco | Unimom.Co | 2018 | — |
| +2 | K190810 | OPERA, OPERA eco | Unimom.Co | 2019 | — |
| +1 | K162870 | CIMLRE F1 and CIMILRE S3 | Cimilre Co., Ltd. | 2017 | — |
| +2 | K201152 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K051926 | Limerick PJ'S Comfort JR Portable Electric Breast PumpSummary page 5…mps have the same intended use and the same ® technological characteristics as the Limerick PJ Comfort (K051926). The general device characteristics and key specifications of the Spectra S1 Plus and Spectra S2 Plus breast pumps and its… | 2005 |
What descends from it? (24)
See all 246 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 31 years and passes through 4 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K181784 (Uzinmedicare Co., 2018) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K051926.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ST Plus and Spectra S2 Plus are single-user, powered breast pumps 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/K150476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150476: Spectra S1Plus and Spectra S2 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150476
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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