Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dhd Diemolding Healthcare Div. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
190 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973532 | STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL | Dhd Diemolding Healthcare Div. | 1998-03-19 | 182 | 0 |
| K970596 | DHD EMERALD PRODUCT | Dhd Diemolding Healthcare Div. | 1997-05-16 | 87 | 0 |
| K961973 | DHD ACE WITH MASK KIT | Dhd Diemolding Healthcare Div. | 1996-08-15 | 87 | 0 |
| K953206 | DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) | Dhd Diemolding Healthcare Div. | 1995-08-28 | 90 | 0 |
| K945118 | EXPIRATORY BREATHING EXERCISER | Dhd Diemolding Healthcare Div. | 1995-01-13 | 87 | 0 |
| K944900 | THERAPEP | Dhd Diemolding Healthcare Div. | 1995-01-06 | 94 | 0 |
| K926301 | ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO | Dhd Diemolding Healthcare Div. | 1993-07-21 | 218 | 0 |
| K922537 | DURALIFE | Dhd Diemolding Healthcare Div. | 1992-12-04 | 190 | 0 |
| K913726 | DURALIFE(TM) | Dhd Diemolding Healthcare Div. | 1992-02-07 | 171 | 0 |
| K913326 | DHD METERED DOSE INHALER (MDI) SPACER | Dhd Diemolding Healthcare Div. | 1992-01-07 | 166 | 0 |
| K911294 | ULTRASET CATHETER | Dhd Diemolding Healthcare Div. | 1991-06-10 | 77 | 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