510(k) Report

FDA applicant

Thermedics, Inc.

Woburn, MA4 decisions1985–19890 recalls

FDA records 4 decisions for Thermedics, Inc. (Woburn, MA) from 1985 to 1989: 4 510(k) clearances. Most are in product codes FJS (Catheter, Peritoneal, Long-Term Indwelling) and DQY (Catheter, Percutaneous). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Thermedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Thermedics, 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?

  • FJSCatheter, Peritoneal, Long-Term Indwelling1decision
  • DQYCatheter, Percutaneous1decision
  • FKOCatheter, Peritoneal Dialysis, Single Use1decision
  • NADDressing, Wound, Occlusive1decision

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.

  • K894131Dermaport Vascular Access Device Model NO. 50-1000Thermedics, Inc. · 19892cite it

What has FDA decided for it lately?

  • K894131Dermaport Vascular Access Device Model NO. 50-1000Thermedics, Inc. · 1989
  • K863128Peritoneal Dialysis CathetersThermedics, Inc. · 1986
  • K854966Acute Peritoneal Dialysis CathetersThermedics, Inc. · 1986
  • K850076Wound Dressing Model ZB-6Thermedics, Inc. · 1985

All 4 as Thermedics, Inc. →