510(k) Report

FDA applicant

Equal Diagnostics, Inc.

Exton, PA2 decisions1996–19980 recalls

FDA records 2 decisions for Equal Diagnostics, Inc. (Exton, PA) from 1996 to 1998: 2 510(k) clearances. Most are in product codes HIH (Hysteroscope (And Accessories)) and CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase). 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 Equal Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Equal Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Equal Diagnostics, 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?

  • HIHHysteroscope (And Accessories)1decision
  • CHILipase-Esterase, Enzymatic, Photometric, Lipase1decision

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.

  • K981800Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606Equal Diagnostics, Inc. · 19981cites it

What has FDA decided for it lately?

  • K981800Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606Equal Diagnostics, Inc. · 1998
  • K961179Sentinel Lipase Liquid Model 17.401BEqual Diagnostics, Inc. · 1996

All 2 as Equal Diagnostics, Inc. →