Dhd Healthcare Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Dhd Healthcare Corp.” (first 1998, latest 2004), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Review panels
- Anesthesiology (7)
- General Hospital (1)
Most recent Dhd Healthcare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040718 | TRUST | CAF | 2004-04-02 | 14 |
| K002768 | ACAPELLA | BWF | 2000-12-05 | 90 |
| K003146 | CLINIFLO INCENTIVE SPIROMETER | BWF | 2000-11-21 | 42 |
| K991561 | ROADRUNNER, PEP THERAPY DEVICE | BWF | 1999-11-10 | 190 |
| K991300 | BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE | BWF | 1999-07-12 | 87 |
| K983467 | THERAPEP | BWF | 1999-04-02 | 189 |
| K980662 | LICHEN, BACTERIAL IN LINE BREATHING FILTER | CAH | 1998-09-14 | 206 |
| K981167 | STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT | CAF | 1998-06-18 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Dhd Healthcare Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Dhd Healthcare Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Dhd Healthcare Corp.?
FDA lists 8 510(k) clearances under the applicant name “Dhd Healthcare Corp.” (first 1998, latest 2004), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dhd Healthcare Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dhd Healthcare Corp. is 88 days.
Which FDA product codes appear under Dhd Healthcare Corp.?
The most frequent FDA product codes under this applicant name are BWF (Spirometer, Therapeutic (Incentive), 5); CAF (Nebulizer (Direct Patient Interface), 2); CAH (Filter, Bacterial, Breathing-Circuit, 1).
Next steps
- See all 8 Dhd Healthcare Corp. clearances with predicates and recalls
- Run predicate analysis for product code BWF, Dhd Healthcare Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.