510(k) Report

FDA applicant

Hne Healthcare, Inc.

Manalapan, NJ2 decisions1995–19960 recalls

FDA records 2 decisions for Hne Healthcare, Inc. (Manalapan, NJ) from 1995 to 1996: 2 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and ITX (Transducer, Ultrasonic, Diagnostic). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Hne Healthcare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JOWSleeve, Limb, Compressible1decision
  • ITXTransducer, Ultrasonic, Diagnostic1decision

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K961166Flowtron Excel PumpHne Healthcare, Inc. · 19964cite it
  • K946300Dopplex Surgical ProbesHne Healthcare, Inc. · 19951cites it

What has FDA decided for it lately?

  • K961166Flowtron Excel PumpHne Healthcare, Inc. · 1996
  • K946300Dopplex Surgical ProbesHne Healthcare, Inc. · 1995

All 2 as Hne Healthcare, Inc. →