510(k) · Cleared
ClearedOPERA, OPERA eco
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimom.Co · HGX Pump, Breast, Powered
Cleared on Aug 30, 2019 as substantially equivalent to K180075 (Unimom.Co, 2018) after a 154-day review. Its family tree reaches back 6 generations to 1985. 5 later devices descend from it.
- Decided
- Aug 30, 2019
- Review
- 154 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K850705 (1985). 9 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK850705 The White River Porta-Elec-Breast PumpNatural Technologies, Inc. · 1985
- 5 generations backK971543 Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997
- 4 generations backK012275 PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002
- 3 generations backK051926 Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005
- 2 generations backK150476 Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016
- 1 generation backK180075 MINUET LCD, MINUET LCD ecoUnimom.Co · 2018
- This deviceK190810 OPERA, OPERA ecoUnimom.Co · 2019
- Descendant · cites it directly · 1 of its ownK242111 VivaceUnimom.Co · 2025
- Descendant · cites it directly · 1 of its ownK202045 imani i1Imani Co. · 2021
- Descendant · 2 generations on · 0 of its ownK260643 Cimilre Dual MaxCimilre Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK232047 VivaceUnimom.Co · 2024
- Descendant · 2 generations on · 0 of its ownK222573 imani i2Plus Breast PumpImani Co. · 2023
Most influential descendants
Showing 5 of 5 · See all- K242111VivaceUnimom.Co · 2025 · cites it directly1descendant
- K202045imani i1Imani Co. · 2021 · cites it directly1descendant
- K260643Cimilre Dual MaxCimilre Co., Ltd. · 2026 · 2 generations on0descendants
- K232047VivaceUnimom.Co · 2024 · cites it directly0descendants
- K222573imani i2Plus Breast PumpImani Co. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850705 | The White River Porta-Elec-Breast Pump | Natural Technologies, Inc. | 1985 | — |
| −5 | K971543 | Luxmatic 12-15 Isc Portable Electric Breast Pump | Kaweco GmbH | 1997 | — |
| −4 | K012275 | PJ.S Comfort Portable Electric Breast Pump | Limerick, Inc. | 2002 | — |
| −3 | K051926 | Limerick PJ'S Comfort JR Portable Electric Breast Pump | Limerick, Inc. | 2005 | — |
| −2 | K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016 | — |
| −1 | K180075 | MINUET LCD, MINUET LCD eco | Unimom.Co | 2018 | — |
| 0 (this device) | K190810 | OPERA, OPERA eco | Unimom.Co | 2019 | — |
| +1 | K242111 | Vivace | Unimom.Co | 2025 | — |
| +1 | K202045 | imani i1 | Imani Co. | 2021 | — |
| +2 | K260643 | Cimilre Dual Max | Cimilre Co., Ltd. | 2026 | — |
| +1 | K232047 | Vivace | Unimom.Co | 2024 | — |
| +2 | K222573 | imani i2Plus Breast Pump | Imani Co. | 2023 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K180075 | MINUET LCD, MINUET LCD ecoSummary page 4…Identification of Predicate Device The identified predicate devices within this submission are shown as follow; 510(k) Number: K180075 Applicant: Unimom Co. Trade/Device Name: MINUET LCD, MINUET LCD eco… | 2018 |
What descends from it? (5)
3 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 34 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K242111 (Unimom.Co, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 OPERA and OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190810 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190810: OPERA, OPERA eco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190810
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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