510(k) Report

510(k) · Cleared

Recalled · 2010

Medela Breast-Pump Lactina

K875300510(k) TraditionalCleared Apr 6, 198899-day reviewClass II21 CFR 884.5160Recalls 3

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 Apr 6, 1988 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 149 later devices descend from it. It has been recalled 3 times.

Decided
Apr 6, 1988
Review
99 days
Class
Class II
Product code
HGX
Recalls
3
Predicates
0

149 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared1997: 1 descendant cleared2019: 7 descendants cleared2004: 1 descendant cleared2003: 1 descendant cleared2006: 1 descendant cleared2013: 2 descendants cleared1999: 1 descendant cleared2010: 2 descendants cleared2012: 4 descendants cleared2002: 1 descendant cleared2005: 1 descendant cleared2016: 4 descendants cleared2015: 6 descendants cleared2017: 4 descendants cleared2023: 12 descendants cleared2020: 7 descendants cleared2026: 27 descendants cleared2014: 1 descendant cleared2021: 12 descendants cleared2025: 21 descendants cleared2018: 3 descendants cleared2022: 13 descendants cleared2024: 15 descendants cleared1990200020102020
  1. This deviceK875300 Medela Breast-Pump LactinaMedela, Inc. · 1988
  2. Descendant · cites it directly · 148 of its ownK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · Recalled
  3. Descendant · 2 generations on · 100 of its ownK092783 DEBPEnko, Ltd. · 2009
  4. Descendant · 3 generations on · 63 of its ownK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
  5. Descendant · 4 generations on · 55 of its ownK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
  6. Descendant · 3 generations on · 32 of its ownK162415 Spectra 9PlusUzinmedicare Company · 2017

Showing 5 of 149 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12002: 12003: 12004: 12005: 12006: 12009: 22010: 22012: 42013: 22014: 12015: 62016: 42017: 42018: 32019: 72020: 72021: 122022: 132023: 122024: 152025: 212026: 27
1997high 27 (2026) · low 0 (1998)2026

Most influential descendants

Showing 5 of 149 · See all
  • K973501Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · cites it directly148descendants
  • K092783DEBPEnko, Ltd. · 2009 · 2 generations on100descendants
  • K122474Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012 · 3 generations on63descendants
  • K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantyMedela AG · 2015 · 4 generations on55descendants
  • K162415Spectra 9PlusUzinmedicare Company · 2017 · 3 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K875300Medela Breast-Pump LactinaMedela, Inc.1988—
+1K973501Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG19971
+2K092783DEBPEnko, Ltd.2009—
+3K122474Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San2012—
+4K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor…Medela AG2015—
+3K162415Spectra 9PlusUzinmedicare Company2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200210
200310
200410
200510
200610
200920
201020
201240
201320
201410
201560
201640
201740
201830
201970
202070
2021120
2022130
2023120
2024150
2025210
2026270
FIG. 1 — Lineage of K875300, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (149)

See all 149

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

NumberDeviceApplicantDecidedDescendants
K973501Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG1997148
K081932Endeare Breast PumpHygeia Medical, Inc.20092

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 6, 2010Not classifiedZ-2486-2010PackagingThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Aug 6, 2010Not classifiedZ-2484-2010PackagingThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Aug 6, 2010Not classifiedZ-2485-2010PackagingThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K973501 (Ameda Medizintechnik AG, 1997) has gone furthest, with 148 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/K875300 · printed Nov 6, 2026

Cite this page

510(k) Report. “K875300: Medela Breast-Pump Lactina.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K875300

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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