510(k) · Cleared
ClearedHandheld Manual Breast Pump (Avent Manual Breast Pump)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Electronics UK Limited · HGY Pump, Breast, Non-Powered
Cleared on Nov 5, 2010 as substantially equivalent to K823591 (Burditt & Calkins-Siemens-Elema, 1982) and 2 other predicates after a 155-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- Nov 5, 2010
- Review
- 155 days
- Class
- Class I
- Product code
- HGY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K801862 (1980). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 3 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 2 generations backK031614 Medela Pump in Style Advanced Breast PumpMedela, Inc. · 2003 · Recalled
- 1 generation backK052047 Isis IQ Uno Handheld Electronic Breast Pump, Model 101Avent America, Inc. · 2005
- This deviceK101538 Handheld Manual Breast Pump (Avent Manual Breast Pump)Philips Electronics UK Limited · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −3 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −2 | K031614 | Medela Pump in Style Advanced Breast Pump | Medela, Inc. | 2003 | 1 |
| −1 | K052047 | Isis IQ Uno Handheld Electronic Breast Pump, Model 101 | Avent America, Inc. | 2005 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1995 | 2 | 0 |
| 2003 | 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 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? (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 |
|---|---|---|---|
| * | K823591 | Ameda Hand Breast PumpSummary page 1…Product Code: ROY Classification Regulation: 21 C.F.R. § 884.5150 Predicate Devices: Ameda Hand Breast Pump (K823 59 1) ISIS IQ Uno Handheld Electronic Breast Pump, Model 101 (K052047) Medela Manual Breas… | 1982 |
| * | K052047 | Isis IQ Uno Handheld Electronic Breast Pump, Model 101Summary page 1…n: 21 C.F.R. § 884.5150 Predicate Devices: Ameda Hand Breast Pump (K823 59 1) ISIS IQ Uno Handheld Electronic Breast Pump, Model 101 (K052047) Medela Manual Breast Pump (K828340) Device Description: The Philips Avent Manual Breast Pump expresses a… | 2005 |
| * | K823840 | Medela Namual Breast Pump Our reading of the summary gave K828340, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped in this product code whose FDA name shares the summary’s words. | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 9 ancestors have a recall of any class.
How does its category compare?
All HGY devicesHGY Pump, Breast, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Philips Avent Manual 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/K101538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101538: Handheld Manual Breast Pump (Avent Manual Breast Pump).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101538
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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