510(k) Report

FDA applicant

Clincal Instruments Corp.

Dudley, MA8 decisions1977–19914 recalls

FDA records 8 decisions for Clincal Instruments Corp. (Dudley, MA) from 1977 to 1991: 8 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and GBP (Catheter, Multiple Lumen). 4 recalls are 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 Clincal Instruments Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clincal Instruments Corp. since 2007.

Recalls per year

1in 2016

2009: 32016: 1
2007high 3 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Clincal Instruments 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?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • GBPCatheter, Multiple Lumen1decision
  • HGMSystem, Monitoring, Perinatal1decision
  • DYGCatheter, Flow Directed1decision
  • DXECatheter, Embolectomy1decision
  • DYBIntroducer, Catheter1decision

Also: DQT (1).

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.

  • K902327Embolectomy CatheterClincal Instruments Corp. · 19911cites it

What has FDA decided for it lately?

  • K902327Embolectomy CatheterClincal Instruments Corp. · 19914 recalls
  • K860743Carotid Bypass Shunt with Sampling ArmClincal Instruments Corp. · 1986
  • K860742Carotid Bypass ShuntClincal Instruments Corp. · 1986
  • K852704Tweetheart #102 Fetal/Neonatal Heartbeat AnnunciatClincal Instruments Corp. · 1985
  • K844918Occlusion & Occlusion-IrrigationClincal Instruments Corp. · 1985
  • K821220Multilumen Intravenous Infusion CatheterClincal Instruments Corp. · 1982
  • K790034IntroducersClincal Instruments Corp. · 1979
  • K771043Swan GanzClincal Instruments Corp. · 1977

All 8 as Clincal Instruments Corp. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K902327Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for…Jul 7, 2016Class II
  • K902327Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single…Mar 25, 2009
  • K902327Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single…Mar 25, 2009
  • K902327Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single…Mar 25, 2009