510(k) Report

FDA applicant

Datrend Systems, Inc.

Richmond, British Columbia, CA2 decisions1998–20070 recalls

FDA records 2 decisions for Datrend Systems, Inc. (Richmond, British Columbia, CA) from 1998 to 2007: 2 510(k) clearances. Most are in product codes DRL (Tester, Defibrillator) and MRZ (Accessories, Pump, Infusion). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Datrend Systems, Inc.’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?

  • DRLTester, Defibrillator1decision
  • MRZAccessories, Pump, Infusion1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K062099Phase 3, Model DT-1Datrend Systems, Inc. · 2007
  • K980165Infutest 2000 Infusion Device AnalyzerDatrend Systems, Inc. · 1998

All 2 as Datrend Systems, Inc. →