510(k) · Cleared
Recalled · Class III · 2017Expresse and Premier Powered Breast Pumps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameda Medizintechnik AG · HGX Pump, Breast, Powered
Cleared on Dec 11, 1997 as substantially equivalent to K875300 (Medela, Inc., 1988) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1988. 148 later devices descend from it. It has been recalled once.
- Decided
- Dec 11, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- HGX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K875300 (1988). 2 ancestors in all. 148 later devices descend from it, 13 citing it directly.
- Root · 1 generation backK875300 Medela Breast-Pump LactinaMedela, Inc. · 1988 · Recalled
- This deviceK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997
- Descendant · cites it directly · 100 of its ownK092783 DEBPEnko, Ltd. · 2009
- Descendant · 2 generations on · 63 of its ownK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- Descendant · 3 generations on · 55 of its ownK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- Descendant · 2 generations on · 32 of its ownK162415 Spectra 9PlusUzinmedicare Company · 2017
- Descendant · 3 generations on · 30 of its ownK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
Showing 5 of 148 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 148 · See all- K092783DEBPEnko, Ltd. · 2009 · cites it directly100descendants
- K122474Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012 · 2 generations on63descendants
- K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantyMedela AG · 2015 · 3 generations on55descendants
- K162415Spectra 9PlusUzinmedicare Company · 2017 · 2 generations on32descendants
- K163136Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875300 | Medela Breast-Pump Lactina | Medela, Inc. | 1988 | 3 |
| 0 (this device) | K973501 | Expresse and Premier Powered Breast Pumps | Ameda Medizintechnik AG | 1997 | — |
| +1 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| +2 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| +3 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| +2 | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
| +3 | K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 12 | 0 |
| 2022 | 13 | 0 |
| 2023 | 12 | 0 |
| 2024 | 15 | 0 |
| 2025 | 21 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K875300 | Medela Breast-Pump LactinaSummary page 1…ry Prepared - September 12, 1997 2. Name of Device: Expresse and Premier Powered Breast Pumps 3. Name of Predicate Device(s) The Medela Lactina Breast Pump by Medela, K875300, April 6, 1988 « The Medela Pump In Style Breast Pump (not known) « Egnell Elite Breast Pump by Ameda/Egnell, K950531, September… | 1988 |
| * | K950531 | Egnell EliteSummary page 1…evice(s) The Medela Lactina Breast Pump by Medela, K875300, April 6, 1988 « The Medela Pump In Style Breast Pump (not known) « Egnell Elite Breast Pump by Ameda/Egnell, K950531, September 22, 1995 4. Description of Device The Expresse and Premier powered breast pumps are intended to express the mother’s… | 1995 |
| * | — | Medela Pump In Style Breast Pump Named without a submission number |
What descends from it? (148)
See all 14813 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092783 | DEBP | 2009 | 100 |
| K051926 | Limerick PJ'S Comfort JR Portable Electric Breast Pump | 2005 | 26 |
| K113664 | Closer to Nature Electric Breast Pump | 2012 | 5 |
| K022594 | Playtex Breast Pump | 2002 | 3 |
| K131153 | Evenflo Advanced Double Electric Breast Pump | 2013 | 2 |
| K081932 | Endeare Breast Pump | 2009 | 2 |
| K061013 | Playtex Embrace Petite Breast Pump | 2006 | 1 |
| K983776 | Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast Pump | 1999 | 1 |
| K121478 | Nuk Expressivetm Double Electric Breast Pump | 2013 | 0 |
| K093145 | Spectra Series Breast Pump | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2017 | Class III | Z-0616-2018 | Employee error | Two specific lots was incorrectly manufactured containing a UK power adapter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother’s milk of a nursing woman for the purpose of feeding the collected milk to a baby.
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/K973501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973501: Expresse and Premier Powered Breast Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973501
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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