510(k) · Cleared
ClearedPJ.S Comfort 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 Jan 7, 2002 as substantially equivalent to K850705 (Natural Technologies, Inc., 1985) and 1 other predicate after a 172-day review. Its family tree reaches back 2 generations to 1985. 27 later devices descend from it.
- Decided
- Jan 7, 2002
- Review
- 172 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K850705 (1985). 27 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK850705 The White River Porta-Elec-Breast PumpNatural Technologies, Inc. · 1985
- 1 generation backK971543 Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997
- This deviceK012275 PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002
- Descendant · cites it directly · 26 of its ownK051926 Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005
- Descendant · 2 generations on · 24 of its ownK150476 Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016
- Descendant · 3 generations on · 7 of its ownK181784 Spectra S3 PlusUzinmedicare Co. · 2018
- Descendant · 3 generations on · 6 of its ownK180075 MINUET LCD, MINUET LCD ecoUnimom.Co · 2018
- Descendant · 4 generations on · 5 of its ownK190810 OPERA, OPERA ecoUnimom.Co · 2019
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K051926Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005 · cites it directly26descendants
- K150476Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016 · 2 generations on24descendants
- K181784Spectra S3 PlusUzinmedicare Co. · 2018 · 3 generations on7descendants
- K180075MINUET LCD, MINUET LCD ecoUnimom.Co · 2018 · 3 generations on6descendants
- K190810OPERA, OPERA ecoUnimom.Co · 2019 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850705 | The White River Porta-Elec-Breast Pump | Natural Technologies, Inc. | 1985 | — |
| −1 | K971543 | Luxmatic 12-15 Isc Portable Electric Breast Pump | Kaweco GmbH | 1997 | — |
| 0 (this device) | 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 | — |
| +2 | K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016 | — |
| +3 | K181784 | Spectra S3 Plus | Uzinmedicare Co. | 2018 | — |
| +3 | K180075 | MINUET LCD, MINUET LCD eco | Unimom.Co | 2018 | — |
| +4 | K190810 | OPERA, OPERA eco | Unimom.Co | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K850705 | The White River Porta-Elec-Breast PumpSummary page 1…bank, California 91504 Date Summary Prepared: March 27, 2001 2. Name of the Device: pi*s comfort® Portable Electric Breast Pump 3. Predicate Devices Information: - K#850705, White River Portable Electric Breast Pump, White Rive, Division of Natural Technologies, Inc. K971543, Luxmatic 12-15 ISC Porta… | 1985 |
| * | K971543 | Luxmatic 12-15 Isc Portable Electric Breast PumpSummary page 1…table Electric Breast Pump 3. Predicate Devices Information: - K#850705, White River Portable Electric Breast Pump, White Rive, Division of Natural Technologies, Inc. K971543, Luxmatic 12-15 ISC Portable electric Breast Pump, KaweCo GmbH ' 4. Device Description: pi*s comfort® Portable Electric Breast… | 1997 |
What descends from it? (27)
See all 272 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 17 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051926 (Limerick, Inc., 2005) has gone furthest, with 26 descendants of its own.
- 1 other device also cites its predicate K850705.
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 (diaphragm-type) suction device is to express milk from the breast of lactating women.
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/K012275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012275: PJ.S Comfort 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/K012275
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026