510(k) Report

FDA applicant

Biolab Equipment Canada, Ltd.

Thornhill, Ontario, CA1 decision2003–20030 recalls

FDA records 1 decision for Biolab Equipment Canada, Ltd. (Thornhill, Ontario, CA) in 2003: 1 510(k) clearance. All are in product code FIP (Subsystem, Water Purification). Its devices cite 2 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, gastroenterology and urology panel, where it files most

How often FDA has decided Biolab Equipment Canada, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biolab Equipment Canada, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biolab Equipment Canada, Ltd.’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?

  • FIPSubsystem, Water Purification1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K030348Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO System,Biopure Water…Biolab Equipment Canada, Ltd. · 20032cite it

What has FDA decided for it lately?

  • K030348Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO System,Biopure Water…Biolab Equipment Canada, Ltd. · 2003

The one decision as Biolab Equipment Canada, Ltd. →