510(k) · Cleared
ClearedLimerick PJ'S Comfort JR Portable Electric Breast Pump
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 Dec 12, 2005 as substantially equivalent to K012275 (Limerick, Inc., 2002) and 1 other predicate after a 147-day review. Its family tree reaches back 3 generations to 1985. 26 later devices descend from it.
- Decided
- Dec 12, 2005
- Review
- 147 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K850705 (1985). 6 ancestors in all. 26 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK850705 The White River Porta-Elec-Breast PumpNatural Technologies, Inc. · 1985
- 2 generations backK971543 Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997
- 1 generation backK012275 PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002
- This deviceK051926 Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005
- Descendant · cites it directly · 24 of its ownK150476 Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016
- Descendant · 2 generations on · 7 of its ownK181784 Spectra S3 PlusUzinmedicare Co. · 2018
- Descendant · 2 generations on · 6 of its ownK180075 MINUET LCD, MINUET LCD ecoUnimom.Co · 2018
- Descendant · 3 generations on · 5 of its ownK190810 OPERA, OPERA ecoUnimom.Co · 2019
- Descendant · 2 generations on · 4 of its ownK162870 CIMLRE F1 and CIMILRE S3Cimilre Co., Ltd. · 2017
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K150476Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016 · cites it directly24descendants
- K181784Spectra S3 PlusUzinmedicare Co. · 2018 · 2 generations on7descendants
- K180075MINUET LCD, MINUET LCD ecoUnimom.Co · 2018 · 2 generations on6descendants
- K190810OPERA, OPERA ecoUnimom.Co · 2019 · 3 generations on5descendants
- K162870CIMLRE F1 and CIMILRE S3Cimilre Co., Ltd. · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850705 | The White River Porta-Elec-Breast Pump | Natural Technologies, Inc. | 1985 | — |
| −2 | K971543 | Luxmatic 12-15 Isc Portable Electric Breast Pump | Kaweco GmbH | 1997 | — |
| −1 | K012275 | PJ.S Comfort Portable Electric Breast Pump | Limerick, Inc. | 2002 | — |
| 0 (this device) | K051926 | Limerick PJ'S Comfort JR Portable Electric Breast Pump | Limerick, Inc. | 2005 | — |
| +1 | K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016 | — |
| +2 | K181784 | Spectra S3 Plus | Uzinmedicare Co. | 2018 | — |
| +2 | K180075 | MINUET LCD, MINUET LCD eco | Unimom.Co | 2018 | — |
| +3 | K190810 | OPERA, OPERA eco | Unimom.Co | 2019 | — |
| +2 | K162870 | CIMLRE F1 and CIMILRE S3 | Cimilre Co., Ltd. | 2017 | — |
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 |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K012275 | PJ.S Comfort Portable Electric Breast PumpSummary page 1…05 2. Name of the Device: pj's comfort jr.® Portable Electric Breast Pump Predicate Devices Information: pj's comfort®Portable Breast Pump K012275 Medela Pump In Style Breast Pump (510 (k) not known) K97350… | 2002 |
| * | K973501 | Expresse and Premier Powered Breast PumpsSummary page 1…pj's comfort®Portable Breast Pump K012275 Medela Pump In Style Breast Pump (510 (k) not known) K973501 Ameda Egnell Expresse and Premier Powered Breast pump 3. DevceDecrpton… | 1997 |
| * | — | Medela Pump In Style Breast Pump Named without a submission number |
What descends from it? (26)
See all 262 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 20 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K150476 (Uzinmedicare Co., 2016) has gone furthest, with 24 descendants of its own.
- 1 other device also cites its predicate K012275.
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 intended use of the electrically powered suction device is to express milk from the breast of lactating women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051926 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051926: Limerick PJ'S Comfort JR Portable Electric Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051926
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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