510(k) · Cleared
ClearedHi bebe plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bistos Co., Ltd. · HGX Pump, Breast, Powered
Cleared on Sep 1, 2016 as substantially equivalent to K150499 (Medela AG, 2015) after a 212-day review. Its family tree reaches back 6 generations to 1980. 3 later devices descend from it.
- Decided
- Sep 1, 2016
- Review
- 212 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K801862 (1980). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 5 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 4 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 3 generations backK092783 DEBPEnko, Ltd. · 2009
- 2 generations backK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- 1 generation backK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- This deviceK160274 Hi bebe plusBistos Co., Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK200675 Hi bebe super (Models BT-150S and BT-150L)Bistos Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK251512 Hi bebe super (BT-150B)Bistos Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK211016 Powered Breast Pump (Models 7V and 7X)Haenim Co., Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −6 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −5 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −4 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −3 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −2 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| −1 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| 0 (this device) | K160274 | Hi bebe plus | Bistos Co., Ltd. | 2016 | — |
| +1 | K200675 | Hi bebe super (Models BT-150S and BT-150L) | Bistos Co., Ltd. | 2021 | — |
| +2 | K251512 | Hi bebe super (BT-150B) | Bistos Co., Ltd. | 2025 | — |
| +2 | K211016 | Powered Breast Pump (Models 7V and 7X) | Haenim Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantySummary page 4…Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty 510(k) Number K150499 Regulation Name Powered Breast Pump Regulation Number 21 CFR 884.5160 (Product Code… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200675 | Hi bebe super (Models BT-150S and BT-150L) | 2021 | 2 |
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 36 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K200675 (Bistos Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K150499.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Hi bebeplus, model BT-100, electric breast pump is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160274: Hi bebe plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160274
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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