Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dhd Healthcare Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
206 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040718 | TRUST | Dhd Healthcare Corp. | 2004-04-02 | 14 | 0 |
| K002768 | ACAPELLA | Dhd Healthcare Corp. | 2000-12-05 | 90 | 0 |
| K003146 | CLINIFLO INCENTIVE SPIROMETER | Dhd Healthcare Corp. | 2000-11-21 | 42 | 0 |
| K991561 | ROADRUNNER, PEP THERAPY DEVICE | Dhd Healthcare Corp. | 1999-11-10 | 190 | 0 |
| K991300 | BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE | Dhd Healthcare Corp. | 1999-07-12 | 87 | 0 |
| K983467 | THERAPEP | Dhd Healthcare Corp. | 1999-04-02 | 189 | 0 |
| K980662 | LICHEN, BACTERIAL IN LINE BREATHING FILTER | Dhd Healthcare Corp. | 1998-09-14 | 206 | 0 |
| K981167 | STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT | Dhd Healthcare Corp. | 1998-06-18 | 78 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda