510(k) Report

FDA applicant

Harbor Medical, Inc.

Longwood, FL2 decisions1986–19860 recalls

FDA records 2 decisions for Harbor Medical, Inc. (Longwood, FL) in 1986: 2 510(k) clearances. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

FDA decisions per year

No FDA decision for Harbor Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Harbor Medical, 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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What has FDA decided for it lately?

  • K860507Harbor Medical Dressing TrayHarbor Medical, Inc. · 1986
  • K860506Harbor Medical Respiratory TrayHarbor Medical, Inc. · 1986

All 2 as Harbor Medical, Inc. →

Other applicant names beginning “Harbor”

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

Harbor Medical Devices, Inc. 7Harbor Medtech, Inc. 2