510(k) · Cleared
ClearedPlaytex Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Playtex Products, Inc. · HGX Pump, Breast, Powered
Cleared on Nov 1, 2002 as substantially equivalent to K973501 (Ameda Medizintechnik AG, 1997) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1988. 3 later devices descend from it.
- Decided
- Nov 1, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K875300 (1988). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK875300 Medela Breast-Pump LactinaMedela, Inc. · 1988 · Recalled
- 1 generation backK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · Recalled
- This deviceK022594 Playtex Breast PumpPlaytex Products, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK061013 Playtex Embrace Petite Breast PumpPlaytex Products, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK093145 Spectra Series Breast PumpUzinmedicare Co. · 2010
- Descendant · cites it directly · 0 of its ownK043098 Gerber Double Electric Breast PumpGerber Products Co. · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875300 | Medela Breast-Pump Lactina | Medela, Inc. | 1988 | 3 |
| −1 | K973501 | Expresse and Premier Powered Breast Pumps | Ameda Medizintechnik AG | 1997 | 1 |
| 0 (this device) | K022594 | Playtex Breast Pump | Playtex Products, Inc. | 2002 | — |
| +1 | K061013 | Playtex Embrace Petite Breast Pump | Playtex Products, Inc. | 2006 | 1 |
| +2 | K093145 | Spectra Series Breast Pump | Uzinmedicare Co. | 2010 | — |
| +1 | K043098 | Gerber Double Electric Breast Pump | Gerber Products Co. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K973501 | Expresse and Premier Powered Breast PumpsSummary page 1…ompany Product Name 51O(k) Clearance Number Ameda Egnell Express and Premier K973501 Ameda Egnell Elite K950531 Medela… | 1997 |
| * | K950531 | Egnell EliteSummary page 1…Ameda Egnell Express and Premier K973501 Ameda Egnell Elite K950531 Medela Pump-in-Style, K950750 General Description: The Pla.ytex el… | 1995 |
| * | K950750 | Medelas Breast PumpSummary page 1…Ameda Egnell Elite K950531 Medela Pump-in-Style, K950750 General Description: The Pla.ytex electric breast pump is a small, quiet, safe and effective system for expressing milk from a… | 1995 |
What descends from it? (3)
2 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 14 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K061013 (Playtex Products, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate K973501.
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?
An electrically powered breast pump used to express milk from the breast of a lactating woman.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022594 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022594: Playtex Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022594
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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