510(k) · Cleared
ClearedArdo Carum and Calypso Powered Breast Pumps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ardo Medical AG · HGX Pump, Breast, Powered
Cleared on Oct 17, 2014 as substantially equivalent to K020518 (Medela, Inc., 2002) after a 112-day review. Its family tree reaches back 2 generations to 1980. 3 later devices descend from it.
- Decided
- Oct 17, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801862 (1980). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 1 generation backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- This deviceK141742 Ardo Carum and Calypso Powered Breast PumpsArdo Medical AG · 2014
- Descendant · cites it directly · 0 of its ownK172067 One Mum PumpsetArdo Medical AG · 2017
- Descendant · cites it directly · 0 of its ownK163183 Yooeehouse Breast PumpNantong Poly Technology Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK150721 ARDO Calypso Pro Powered Breast PumpArdo Medical AG · 2015
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 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −1 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| 0 (this device) | K141742 | Ardo Carum and Calypso Powered Breast Pumps | Ardo Medical AG | 2014 | — |
| +1 | K172067 | One Mum Pumpset | Ardo Medical AG | 2017 | — |
| +1 | K163183 | Yooeehouse Breast Pump | Nantong Poly Technology Co., Ltd. | 2017 | — |
| +1 | K150721 | ARDO Calypso Pro Powered Breast Pump | Ardo Medical AG | 2015 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K020518 | Medela Symphony Breast Pump, Model 024Summary page 4…Common or Usual Name Powered breast pump Classification Name HGX, Powered breast pump 21 C.F.R. § 884.5160 Predicate Device Medela Symphony Breast Pump Model 024 (K020518). Device Description ARDO Carum and Calypso Powered Breast Pumps consist of the breast milk pump and a pump set (single or doub… | 2002 |
What descends from it? (3)
3 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 34 years and passes through 2 companies; a new generation was cleared every 21.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K172067 (Ardo Medical AG, 2017) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K020518.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ARDO Carum powered breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users. The ARDO Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor…
Read the full statement (141 words)
The ARDO Carum powered breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.
The ARDO Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.
The ARDO Pumpset should be used in combination with ARDO breast pumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141742: Ardo Carum and Calypso 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/K141742
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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