510(k) Report

FDA applicant

The First Years, Inc.

Avon, MA4 decisions1997–20040 recalls

FDA records 4 decisions for The First Years, Inc. (Avon, MA) from 1997 to 2004: 4 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and HGY (Pump, Breast, Non-Powered). 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 The First Years, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The First Years, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like The First Years, 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, Powered3decisions
  • HGYPump, Breast, Non-Powered1decision

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.

  • K032566Natural Comfort Battery/Electric Breast PumpThe First Years, Inc. · 20031cites it

What has FDA decided for it lately?

  • K032845Easy Comfort Deluxe Manual Breast Pump, Model 1187The First Years, Inc. · 2004
  • K033131Natural Comfort Double Electric/Battery Breast Pump, Model 1181/1068The First Years, Inc. · 2003
  • K032566Natural Comfort Battery/Electric Breast PumpThe First Years, Inc. · 2003
  • K964403Simplicity TM Electric/Battery Breast Pump Kit (1068)The First Years, Inc. · 1997

All 4 as The First Years, Inc. →