510(k) · Cleared
ClearedPJ'S Serenity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Limerick, Inc. · HGX Pump, Breast, Powered
Cleared on Feb 20, 2015 as substantially equivalent to K051926 (Limerick, Inc., 2005) and 1 other predicate after a 583-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Feb 20, 2015
- Review
- 583 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K850705 (1985). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK850705 The White River Porta-Elec-Breast PumpNatural Technologies, Inc. · 1985
- 3 generations backK971543 Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997
- 2 generations backK012275 PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002
- 1 generation backK051926 Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005
- This deviceK132220 PJ'S SerenityLimerick, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850705 | The White River Porta-Elec-Breast Pump | Natural Technologies, Inc. | 1985 | — |
| −3 | K971543 | Luxmatic 12-15 Isc Portable Electric Breast Pump | Kaweco GmbH | 1997 | — |
| −2 | K012275 | PJ.S Comfort Portable Electric Breast Pump | Limerick, Inc. | 2002 | — |
| −1 | K051926 | Limerick PJ'S Comfort JR Portable Electric Breast Pump | Limerick, Inc. | 2005 | — |
| 0 (this device) | K132220 | PJ'S Serenity | Limerick, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K051926 | Limerick PJ'S Comfort JR Portable Electric Breast PumpSummary page 4…0 Joan Ortiz Vice President Limerick, Inc. Tel: (818) 566-3060 Fax: (818) 566-1260 PJ’s Serenity Model PJ2012 Powered breast pump Powered breast pump CFR884.5160 HGX K051926, PJ’s Comfort breast pump K012275, PJ’s Comfort portable breast pump Page 1 of 5 Submission Number Device Descr… | 2005 |
| * | K012275 | PJ.S Comfort Portable Electric Breast PumpSummary page 4…ick, Inc. Tel: (818) 566-3060 Fax: (818) 566-1260 PJ’s Serenity Model PJ2012 Powered breast pump Powered breast pump CFR884.5160 HGX K051926, PJ’s Comfort breast pump K012275, PJ’s Comfort portable breast pump Page 1 of 5 Submission Number Device Description: Indications for Use: Tec… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K051926.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Electric Breast Pump, model PJ2012 is used to express and collect milk from the breast to
alleviate engorgement of the breast, maintain the ability of lactation and provide mother’s milk for
future feeding when separation of mother and baby occurs. The device is intended for multiple users.
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/K132220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132220: PJ'S Serenity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132220
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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