510(k) Report

FDA applicant

Target Health, Inc.

New York, NY3 decisions1997–19980 recalls

FDA records 3 decisions for Target Health, Inc. (New York, NY) from 1997 to 1998: 3 510(k) clearances. Most are in product codes MDA (Elastomer, Silicone, For Scar Management) and LXV (Apparatus, Vestibular Analysis). Its devices cite 4 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Target Health, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Target Health, Inc.’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?

  • MDAElastomer, Silicone, For Scar Management2decisions
  • LXVApparatus, Vestibular Analysis1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K971549VMT SystemTarget Health, Inc. · 1998
  • K973271Skar-KareTarget Health, Inc. · 1997
  • K971009Scar CareTarget Health, Inc. · 1997

All 3 as Target Health, Inc. →

Other applicant names beginning “Target”

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

Target Therapeutics 70Target USA, Inc. 1