510(k) · Cleared
Recalled · Class II · 2015Ameda Hygienikit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · HGY Pump, Breast, Non-Powered
Cleared on Aug 15, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 15, 2001
- Review
- 90 days
- Class
- Class I
- Product code
- HGY
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011519 | Ameda Hygienikit | Hollister, Inc. | 2001 | — |
| +1 | K100435 | Ameda Platinum Breast Pump | Evenflo Company, Inc. | 2010 | — |
| +2 | K132882 | Electric Breast Pump | Shantou Xinghe Electrical Apparatuses Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HGY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100435 | Ameda Platinum Breast Pump | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2015 | Class II | Z-1327-2015 | Under Investigation by firm | Devices were not sterilized |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100435 (Evenflo Company, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HGY devicesHGY Pump, Breast, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGY
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HGY
Too few HGY 510(k)s in any year since 2007 to give a median.
Recalls per year · HGY
No recall names HGY since 2007.
Adverse event reports per year · HGY
1in 2025
MAUDE reports naming product code HGY, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K011519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011519: Ameda Hygienikit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011519
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026