510(k) Report

FDA applicant

Dhd Healthcare Corp.

Wampsville, NY8 decisions1998–20041 recall

FDA records 8 decisions for Dhd Healthcare Corp. (Wampsville, NY) from 1998 to 2004: 8 510(k) clearances. Most are in product codes BWF (Spirometer, Therapeutic (Incentive)) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 14 predicates, 1 of them its own earlier devices. 1 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, anesthesiology panel, where it files most

How often FDA has decided Dhd Healthcare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dhd Healthcare Corp. since 2007.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dhd Healthcare 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?

  • BWFSpirometer, Therapeutic (Incentive)5decisions
  • CAFNebulizer (Direct Patient Interface)2decisions
  • CAHFilter, Bacterial, Breathing-Circuit1decision

Whose devices does it build on?

Its devices cite 14 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 1 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.

  • K002768AcapellaDhd Healthcare Corp. · 20007cite it
  • K991561Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 19994cite it
  • K991300Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 19993cite it
  • K983467TherapepDhd Healthcare Corp. · 19992cite it
  • K003146Cliniflo Incentive SpirometerDhd Healthcare Corp. · 20001cites it
  • K040718TRUSTDhd Healthcare Corp. · 20041cites it

What has FDA decided for it lately?

  • K040718TRUSTDhd Healthcare Corp. · 2004
  • K002768AcapellaDhd Healthcare Corp. · 20001 recall
  • K003146Cliniflo Incentive SpirometerDhd Healthcare Corp. · 2000
  • K991561Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
  • K991300Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
  • K983467TherapepDhd Healthcare Corp. · 1999
  • K980662Lichen, Bacterial in Line Breathing FilterDhd Healthcare Corp. · 1998
  • K981167Stealth Pilot Kit/ Stealth Spacer/Face Mask KitDhd Healthcare Corp. · 1998

All 8 as Dhd Healthcare Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K002768Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device…Dec 21, 2020Class II