510(k) Report

FDA applicant

Prime Pacific Health Innovations Corporation

North Vancouver, Bc, CA2 decisions2001–20050 recalls

FDA records 2 decisions for Prime Pacific Health Innovations Corporation (North Vancouver, Bc, CA) from 2001 to 2005: 2 510(k) clearances. All are in product code KPL (Colonic Irrigation System). Its devices cite 1 predicate, 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 Prime Pacific Health Innovations Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prime Pacific Health Innovations Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prime Pacific Health Innovations Corporation 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?

  • KPLColonic Irrigation System2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K050112Pro Fit Disposable Rectal Speculum, Models 8116 and 8117Prime Pacific Health Innovations Corporation · 20051cites it

What has FDA decided for it lately?

  • K050112Pro Fit Disposable Rectal Speculum, Models 8116 and 8117Prime Pacific Health Innovations Corporation · 2005
  • K000031Aquanet, Model EC 2000Prime Pacific Health Innovations Corporation · 2001

All 2 as Prime Pacific Health Innovations Corporation →

Other applicant names beginning “Prime”

FDA records each applicant name separately; these may or may not be the same firm.

Prime Dental Manufacturing, Inc. 9Prime Herbs Corporation 2Prime Medical Products, Inc. 2Prime Horizon, Inc. 1Prime Ideas, Inc. 1Prime Merit Intl. Corp. 1Prime Engineering 1