510(k) · Cleared
ClearedThe White River Porta-Elec-Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natural Technologies, Inc. · HGX Pump, Breast, Powered
Cleared on Jul 11, 1985 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Jul 11, 1985
- Review
- 140 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 2 citing it directly.
- This deviceK850705 The White River Porta-Elec-Breast PumpNatural Technologies, Inc. · 1985
- Descendant · cites it directly · 28 of its ownK971543 Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997
- Descendant · cites it directly · 27 of its ownK012275 PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002
- Descendant · 2 generations on · 26 of its ownK051926 Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005
- Descendant · 3 generations on · 24 of its ownK150476 Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016
- Descendant · 4 generations on · 7 of its ownK181784 Spectra S3 PlusUzinmedicare Co. · 2018
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K971543Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997 · cites it directly28descendants
- K012275PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002 · cites it directly27descendants
- K051926Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005 · 2 generations on26descendants
- K150476Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016 · 3 generations on24descendants
- K181784Spectra S3 PlusUzinmedicare Co. · 2018 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850705 | The White River Porta-Elec-Breast Pump | Natural Technologies, Inc. | 1985 | — |
| +1 | K971543 | Luxmatic 12-15 Isc Portable Electric Breast Pump | Kaweco GmbH | 1997 | — |
| +1 | K012275 | PJ.S Comfort Portable Electric Breast Pump | Limerick, Inc. | 2002 | — |
| +2 | K051926 | Limerick PJ'S Comfort JR Portable Electric Breast Pump | Limerick, Inc. | 2005 | — |
| +3 | K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016 | — |
| +4 | K181784 | Spectra S3 Plus | Uzinmedicare Co. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 292 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?
- Of its descendants, K971543 (Kaweco GmbH, 1997) has gone furthest, with 28 descendants 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.
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 | — |
https://510kreport.com/device/K850705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K850705: The White River Porta-Elec-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/K850705
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026