510(k) Report

FDA applicant

Care Wise Medical Products Corp.

Morgan Hill, CA4 decisions1989–19980 recalls

FDA records 4 decisions for Care Wise Medical Products Corp. (Morgan Hill, CA) from 1989 to 1998: 4 510(k) clearances. All are in product code IZD (Probe, Uptake, Nuclear). Its devices cite 3 predicates, 2 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, radiology panel, where it files most

How often FDA has decided Care Wise Medical Products Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Care Wise Medical Products Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Care Wise Medical Products Corp. 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?

  • IZDProbe, Uptake, Nuclear4decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K922117C-Trak Biopsy SystemCare Wise Medical Products Corp. · 19922cite it
  • K896588Oncoprobe II SystemCare Wise Medical Products Corp. · 19901cites it

What has FDA decided for it lately?

  • K982442C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)Care Wise Medical Products Corp. · 1998
  • K922117C-Trak Biopsy SystemCare Wise Medical Products Corp. · 1992
  • K896588Oncoprobe II SystemCare Wise Medical Products Corp. · 1990
  • K884770Oncoprobe SystemCare Wise Medical Products Corp. · 1989

All 4 as Care Wise Medical Products Corp. →