510(k) Report

FDA applicant

Synthemed Corp.

Mchenry, IL2 decisions1981–20080 recalls

FDA records 2 decisions for Synthemed Corp. (Mchenry, IL) from 1981 to 2008: 2 510(k) clearances. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and LYA (Splint, Intranasal Septal). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

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 Synthemed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Synthemed Corp.’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?

  • DXYImplantable Pacemaker Pulse-Generator1decision
  • LYASplint, Intranasal Septal1decision

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 2 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.

  • K082276Synthemed DeviceSynthemed, Inc. · 20082cite it

What has FDA decided for it lately?

  • K082276Synthemed DeviceSynthemed, Inc. · 2008
  • K812464Synthemed Pulse Generator Vvi Model 1000Synthemed Corp. · 1981

The one decision as Synthemed Corp. →The one decision as Synthemed, Inc. →