510(k) · Cleared
ClearedSpectra S3 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 Nov 30, 2018 as substantially equivalent to K150476 (Uzinmedicare Co., 2016) after a 150-day review. Its family tree reaches back 5 generations to 1985. 7 later devices descend from it.
- Decided
- Nov 30, 2018
- Review
- 150 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K850705 (1985). 8 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK850705 The White River Porta-Elec-Breast PumpNatural Technologies, Inc. · 1985
- 4 generations backK971543 Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997
- 3 generations backK012275 PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002
- 2 generations backK051926 Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005
- 1 generation backK150476 Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016
- This deviceK181784 Spectra S3 PlusUzinmedicare Co. · 2018
- Descendant · cites it directly · 2 of its ownK201152 Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK223084 MilkMate Breast PumpMilkmate Products, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK191208 Spectra CashmereUzinmedicare Co. · 2019
- Descendant · 3 generations on · 0 of its ownK241705 MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use…Milkmate Products, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK221576 Ameda Pearl Electric Breast PumpAmeda, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K201152Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2021 · cites it directly2descendants
- K223084MilkMate Breast PumpMilkmate Products, Inc. · 2023 · 2 generations on1descendant
- K191208Spectra CashmereUzinmedicare Co. · 2019 · cites it directly1descendant
- K241705MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast…Milkmate Products, Inc. · 2024 · 3 generations on0descendants
- K221576Ameda Pearl Electric Breast PumpAmeda, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850705 | The White River Porta-Elec-Breast Pump | Natural Technologies, Inc. | 1985 | — |
| −4 | K971543 | Luxmatic 12-15 Isc Portable Electric Breast Pump | Kaweco GmbH | 1997 | — |
| −3 | 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 | — |
| −1 | K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016 | — |
| 0 (this device) | K181784 | Spectra S3 Plus | Uzinmedicare Co. | 2018 | — |
| +1 | K201152 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2021 | — |
| +2 | K223084 | MilkMate Breast Pump | Milkmate Products, Inc. | 2023 | — |
| +1 | K191208 | Spectra Cashmere | Uzinmedicare Co. | 2019 | — |
| +3 | K241705 | MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm… | Milkmate Products, Inc. | 2024 | — |
| +1 | K221576 | Ameda Pearl Electric Breast Pump | Ameda, Inc. | 2022 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K150476 | Spectra S1Plus and Spectra S2 PlusSummary page 5…Uzinmedicare Co., Spectra S3 Plus Breast Pump REVIEW PANEL: Obstetrics/Gynecology PRODUCT CODE: HGX (pump, breast, powered) REGULATORY CLASS: II PREDICATE DEVICE(S): K150476 Spectra S1 Plus Breast Pump The predicate device has not been subject to a design related recall. DEVICE DESCRIPTION: The Spect… | 2016 |
What descends from it? (7)
4 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 33 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K201152 (Guangdong Horigen Mother & Baby Products Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K150476.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181784: Spectra S3 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181784
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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