510(k) Report

FDA applicant

Medela AG

Mchenry, IL56 decisions1980–202612 recalls

FDA records 56 decisions for Medela AG (Mchenry, IL) from 1980 to 2026: 56 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and OMP (Negative Pressure Wound Therapy Powered…). Since 2016 its 510(k)s took a median of 149 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 70 predicates, 45 of them its own earlier devices. 12 recalls are linked to its devices.

FDA’s records also spell it “Medela, Inc.”, “Medela, LLC”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Medela AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12008: 22012: 12013: 22014: 22015: 52016: 32017: 22018: 32019: 22020: 12021: 12022: 12023: 12024: 12025: 12026 (partial year): 3
2007high 5 (2015) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2019

2008: 12010: 52011: 32018: 22019: 1
2007high 5 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medela AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medela AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HGXPump, Breast, Powered19decisions
  • OMPNegative Pressure Wound Therapy Powered Suction Pump13decisions
  • BTAPump, Portable, Aspiration (Manual Or Powered)10decisions
  • HGYPump, Breast, Non-Powered3decisions
  • HDBExtractor, Vacuum, Fetal3decisions
  • QPBSystem, Suction, Lipoplasty For Removal2decisions

Also: HFS (2), LBI (2), LHB (1), PNR (1).

How long do its 510(k) reviews take?

Since 2016, its 19 510(k)s took a median of 149 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 149 days; 11 of its 19 were faster than that.

Whose devices does it build on?

Its devices cite 70 predicates; 45 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 116 times; 45 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K983552Basic, Median, Dominant, and VarioMedela, Inc. · 19999cite it
  • K950750Medelas Breast PumpMedela, Inc. · 19959cite it
  • K021368Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057Medela AG · 20028cite it
  • K080357Medela Invia Wound TherapyMedela AG · 20087cite it
  • K031614Medela Pump in Style Advanced Breast PumpMedela, Inc. · 20037cite it
  • K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantyMedela AG · 20156cite it

What has FDA decided for it lately?

  • K253510Freestyle Mini Hands-freeMedela, LLC · 2026
  • K253149Motion InBra (YM-8801) wearable breast pumpMedela, LLC · 2026
  • K253498Pump In Style® Pro+Medela, LLC · 2026
  • K251377Magic InBraMedela AG · 2025
  • K232608Duo Hands-free Breast PumpMedela, LLC · 2024
  • K223388Invia® Integrated DressingMedela AG · 2023
  • K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG · 2022
  • K210759Solo, Swing MaxiMedela, LLC · 2021

All 30 as Medela AG →All 19 as Medela, Inc. →All 7 as Medela, LLC →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K170088Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam…Dec 2, 2019Class II
  • K161811Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100Dec 5, 2018Class III
  • K161128Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative…Feb 7, 2018Class II
  • K080357Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare…Jul 27, 2011
  • K950750AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style…Apr 4, 2011
  • K031614Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered…Jan 10, 2011