510(k) Report

510(k) · Cleared

Recalled · 2011

Medelas Breast Pump

K950750510(k) TraditionalCleared Oct 16, 1995241-day reviewClass II21 CFR 884.5160Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medela, Inc. · HGX Pump, Breast, Powered

Cleared on Oct 16, 1995 after a 241-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it. It has been recalled once.

Decided
Oct 16, 1995
Review
241 days
Class
Class II
Product code
HGX
Recalls
1
Predicates
0

31 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 1 descendant cleared2006: 1 descendant cleared1999: 1 descendant cleared2003: 1 descendant cleared2010: 3 descendants cleared2002: 2 descendants cleared2004: 1 descendant cleared2012: 2 descendants cleared2013: 1 descendant cleared2018: 1 descendant cleared2005: 2 descendants cleared2019: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2026: 4 descendants cleared2025: 3 descendants cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950750 Medelas Breast PumpMedela, Inc. · 1995
  2. Descendant · cites it directly · 21 of its ownK031614 Medela Pump in Style Advanced Breast PumpMedela, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 10 of its ownK181937 Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC · 2018
  4. Descendant · 3 generations on · 8 of its ownK200508 Pump In StyleMedela, LLC · 2020
  5. Descendant · 4 generations on · 4 of its ownK213311 Lucy Breast PumpWillow Innovations, Inc. · 2022
  6. Descendant · cites it directly · 3 of its ownK022594 Playtex Breast PumpPlaytex Products, Inc. · 2002

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

1999: 12002: 22003: 12004: 12005: 22006: 12009: 12010: 32011: 12012: 22013: 12015: 12017: 12018: 12019: 12020: 32022: 12025: 32026: 4
1999high 4 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 31 · See all
  • K031614Medela Pump in Style Advanced Breast PumpMedela, Inc. · 2003 · cites it directly21descendants
  • K181937Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC · 2018 · 2 generations on10descendants
  • K200508Pump In StyleMedela, LLC · 2020 · 3 generations on8descendants
  • K213311Lucy Breast PumpWillow Innovations, Inc. · 2022 · 4 generations on4descendants
  • K022594Playtex Breast PumpPlaytex Products, Inc. · 2002 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950750Medelas Breast PumpMedela, Inc.1995—
+1K031614Medela Pump in Style Advanced Breast PumpMedela, Inc.20031
+2K181937Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC2018—
+3K200508Pump In StyleMedela, LLC2020—
+4K213311Lucy Breast PumpWillow Innovations, Inc.2022—
+1K022594Playtex Breast PumpPlaytex Products, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200220
200310
200410
200520
200610
200910
201030
201110
201220
201310
201510
201710
201810
201910
202030
202210
202530
202640
FIG. 1 — Lineage of K950750, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K212180 Wearable Breast Pump (Model S12)score 34.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (31)

See all 31

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031614Medela Pump in Style Advanced Breast PumpMedela, Inc.200321
K022594Playtex Breast PumpPlaytex Products, Inc.20023
K102516Lucina Model MelodiGenadyne Biotechnologies, Inc.20112
K081932Endeare Breast PumpHygeia Medical, Inc.20092
K061013Playtex Embrace Petite Breast PumpPlaytex Products, Inc.20061
K983776Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast PumpEvenflo Co., Inc.19991
K093145Spectra Series Breast PumpUzinmedicare Co.20100
K093648Simplisse Electric Breastfeeding CompanionSimplisse, Inc.20100
K020848NAFD 100Neomatrix, LLC20020

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 4, 2011Not classifiedZ-2386-2011Device DesignThe power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K031614 (Medela, Inc., 2003) has gone furthest, with 21 descendants of its own.

How does its category compare?

All HGX devices

HGX 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

2007: 12008: 22009: 42010: 72011: 22012: 62013: 42014: 32015: 92016: 72017: 82018: 62019: 72020: 92021: 122022: 152023: 152024: 192025: 262026 (partial year): 34
2007high 34 (2026) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGX

122in 2025

2009: 121 days median2010: 103 days median2012: 180 days median2013: 131 days median2014: 120 days median2015: 141 days median2016: 121 days median2017: 159 days median2018: 136 days median2019: 158 days median2020: 128 days median2021: 240 days median2022: 190 days median2023: 167 days median2024: 168 days median2025: 122 days median2026 (partial year): 142 days median
2007high 240 (2021) · low 103 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HGX

1in 2017

2010: 52011: 12017: 1
2007high 5 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HGX

69in 2025

2007: 22008: 22010: 882011: 2402012: 6852013: 8372014: 1,0362015: 4962016: 3732017: 4372018: 2912019: 1682020: 1682021: 1192022: 1542023: 2002024: 1182025: 69
2007high 1,036 (2014) · low 0 (2009)2025

MAUDE reports naming product code HGX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20082—02
2009412100
20107103588
20112—1240
201261800685
201341310837
2014312001,036
201591410496
201671210373
201781591437
201861360291
201971580168
202091280168
2021122400119
2022151900154
2023151670200
2024191680118
202526122069
2026341420—

More from Medela, Inc.

19 FDA decisions under this applicant name. See the company

  • K161811Medela Low Dose Enteral SyringeMedela, Inc. · 20171 recall
  • K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare…Medela, Inc. · 2016
  • K031614Medela Pump in Style Advanced Breast PumpMedela, Inc. · 20031 recall
  • K020518Medela Symphony Breast Pump, Model 024Medela, Inc. · 20023 recalls
  • K984589Phototherapy LampMedela, Inc. · 1999

Recent decisions in HGX

The HGX category page

  • K261782MODO DUO Electric Pump (B11621, B11673)Tomy International, Inc. · 2026
  • K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd. · 2026
  • K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips…Philips Consumer Lifestyle B.V. · 2026
  • K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd. · 2026
  • K260643Cimilre Dual MaxCimilre Co., Ltd. · 2026

https://510kreport.com/device/K950750 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950750: Medelas 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/K950750

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026