510(k) · Cleared
ClearedEvenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evenflo Co., Inc. · HGX Pump, Breast, Powered
Cleared on Apr 26, 1999 as substantially equivalent to K901344 (Medela, Inc., 1990) and 2 other predicates after a 182-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Apr 26, 1999
- Review
- 182 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K875300 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK875300 Medela Breast-Pump LactinaMedela, Inc. · 1988 · Recalled
- 1 generation backK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · Recalled
- This deviceK983776 Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual…Evenflo Co., Inc. · 1999
- Descendant · cites it directly · 0 of its ownK093648 Simplisse Electric Breastfeeding CompanionSimplisse, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093648Simplisse Electric Breastfeeding CompanionSimplisse, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875300 | Medela Breast-Pump Lactina | Medela, Inc. | 1988 | 3 |
| −1 | K973501 | Expresse and Premier Powered Breast Pumps | Ameda Medizintechnik AG | 1997 | 1 |
| 0 (this device) | K983776 | Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast Pump | Evenflo Co., Inc. | 1999 | — |
| +1 | K093648 | Simplisse Electric Breastfeeding Companion | Simplisse, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K901344 | Medela Battery Operated Breast PumpSummary page 1…keted breast pumps: Company Product Name 510(k) Clearance Number Medela, Inc. Little Hearts Deluxe Battery Breast Pump [Unknown] Medela, Inc. Mini-Electric Breast Pump K901344 Medela, Inc. Pump In Style K950750 Ameda Egnell Express and Premiere (Sold as: Purely Yours Breast Pump) K973501 General Descr… | 1990 |
| * | K950750 | Medelas Breast PumpSummary page 1…Name 510(k) Clearance Number Medela, Inc. Little Hearts Deluxe Battery Breast Pump [Unknown] Medela, Inc. Mini-Electric Breast Pump K901344 Medela, Inc. Pump In Style K950750 Ameda Egnell Express and Premiere (Sold as: Purely Yours Breast Pump) K973501 General Description: The Evenflo Comfort Control… | 1995 |
| * | K973501 | Expresse and Premier Powered Breast PumpsSummary page 1…Pump [Unknown] Medela, Inc. Mini-Electric Breast Pump K901344 Medela, Inc. Pump In Style K950750 Ameda Egnell Express and Premiere (Sold as: Purely Yours Breast Pump) K973501 General Description: The Evenflo Comfort Control Adjustable Speed Breast Pump with Automatic Cycling, and the Evenflo Comfort C… | 1997 |
| * | — | Little Hearts Deluxe Battery Breast Pump Named without a submission number |
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 |
|---|---|---|---|
| K093648 | Simplisse Electric Breastfeeding Companion | 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 11 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K093648 (Simplisse, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K901344.
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 Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use battery/electric powered suction devices used to express milk from the breast of lactating women. These devices are not intended for hospital use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983776: Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983776
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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