510(k) Report

FDA applicant

Techdevice Corporation

Watertown, MA4 decisions2006–20111 recall

FDA records 4 decisions for Techdevice Corporation (Watertown, MA) from 2006 to 2011: 4 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and MJN (Catheter, Intravascular Occluding, Temporary). Its devices cite 9 predicates, 1 of them its own earlier devices. 1 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 Techdevice Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Techdevice Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQXWire, Guide, Catheter2decisions
  • MJNCatheter, Intravascular Occluding, Temporary1decision
  • OCYEndoscopic Guidewire, Gastroenterology-Urology1decision

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K053251Techdevice GuidewireTechdevice Corporation · 20063cite it
  • K110241Endologix GuidewireTechdevice Corporation · 20111cites it
  • K051137Techdevice Occlusion Balloon CatheterTechdevice Corporation · 20061cites it

What has FDA decided for it lately?

  • K110241Endologix GuidewireTechdevice Corporation · 2011
  • K053251Techdevice GuidewireTechdevice Corporation · 2006
  • K051137Techdevice Occlusion Balloon CatheterTechdevice Corporation · 20061 recall
  • K053028Techdevice GuidewireTechdevice Corporation · 2006

All 4 as Techdevice Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051137HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The…Jul 16, 2010