510(k) Report

FDA applicant

Avent America, Inc.

Framingham, MA4 decisions1994–20050 recalls

FDA records 4 decisions for Avent America, Inc. (Framingham, MA) from 1994 to 2005: 4 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and HGY (Pump, Breast, Non-Powered). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Avent America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avent America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Avent America, Inc.’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, Powered2decisions
  • HGYPump, Breast, Non-Powered1decision
  • HFSShield, Nipple1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K052047Isis IQ Uno Handheld Electronic Breast Pump, Model 101Avent America, Inc. · 20051cites it

What has FDA decided for it lately?

  • K052047Isis IQ Uno Handheld Electronic Breast Pump, Model 101Avent America, Inc. · 2005
  • K051413Isis IQ Duo Twin Electronic Breast Pump, Model 100Avent America, Inc. · 2005
  • K952035NipletteAvent America, Inc. · 1995
  • K944117Avent Nipple ShieldAvent America, Inc. · 1994

All 4 as Avent America, Inc. →