510(k) Report

FDA applicant

Hoana Medical, Inc.

Honolulu, HI5 decisions2006–20100 recalls

FDA records 5 decisions for Hoana Medical, Inc. (Honolulu, HI) from 2006 to 2010: 5 510(k) clearances. All are in product code DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). Its devices cite 12 predicates, 7 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2010

2008: 12009: 22010: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hoana 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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Which product codes does it file in?

  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)5decisions

Whose devices does it build on?

Its devices cite 12 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 7 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.

  • K052446LG1 Intelligent Medical Vigilance SystemHoana Medical, Inc. · 20064cite it
  • K083534Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 20092cite it
  • K082366Lifebed Patient Vigilance SystemHoana Medical, Inc. · 20082cite it

What has FDA decided for it lately?

  • K100745Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2010
  • K092037Lifegurney Network Patient Vigilance SystemHoana Medical, Inc. · 2009
  • K083534Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2009
  • K082366Lifebed Patient Vigilance SystemHoana Medical, Inc. · 2008
  • K052446LG1 Intelligent Medical Vigilance SystemHoana Medical, Inc. · 2006

All 5 as Hoana Medical, Inc. →