510(k) · Cleared
ClearedIsis IQ Uno Handheld Electronic Breast Pump, Model 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avent America, Inc. · HGX Pump, Breast, Powered
Cleared on Sep 22, 2005 as substantially equivalent to K031614 (Medela, Inc., 2003) and 1 other predicate after a 55-day review. Its family tree reaches back 3 generations to 1980. 1 later device descends from it.
- Decided
- Sep 22, 2005
- Review
- 55 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801862 (1980). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 2 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 1 generation backK031614 Medela Pump in Style Advanced Breast PumpMedela, Inc. · 2003 · Recalled
- This deviceK052047 Isis IQ Uno Handheld Electronic Breast Pump, Model 101Avent America, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK101538 Handheld Manual Breast Pump (Avent Manual Breast Pump)Philips Electronics UK Limited · 2010
Most influential descendants
Showing 1 of 1 · See all- K101538Handheld Manual Breast Pump (Avent Manual Breast Pump)Philips Electronics UK Limited · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −2 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −1 | K031614 | Medela Pump in Style Advanced Breast Pump | Medela, Inc. | 2003 | 1 |
| 0 (this device) | K052047 | Isis IQ Uno Handheld Electronic Breast Pump, Model 101 | Avent America, Inc. | 2005 | — |
| +1 | K101538 | Handheld Manual Breast Pump (Avent Manual Breast Pump) | Philips Electronics UK Limited | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031614 | Medela Pump in Style Advanced Breast PumpSummary page 1…east Pump. The classification name is Powered Breast Pump. 8.4 Name of Predicate Device Medela Pump In Style Advanced Breast Pump, by Medela Inc., K03 1614; and Natural Comfort/Easy Comfort Battery/Electric Breast Pump, by The First Years, K032566. 8.5 Descriptio… | 2003 |
| * | K032566 | Natural Comfort Battery/Electric Breast PumpSummary page 1…Medela Pump In Style Advanced Breast Pump, by Medela Inc., K03 1614; and Natural Comfort/Easy Comfort Battery/Electric Breast Pump, by The First Years, K032566. 8.5 Description of Device The ISIS iQ UNO Handheld Electronic Breast Pump is a safe and effective powered… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101538 | Handheld Manual Breast Pump (Avent Manual Breast Pump) | 2010 | 0 |
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 25 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K101538 (Philips Electronics UK Limited, 2010) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K031614.
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 ISIS iQ UNO Handheld Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052047: Isis IQ Uno Handheld Electronic Breast Pump, Model 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052047
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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