Dhd Diemolding Healthcare Div.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Dhd Diemolding Healthcare Div.” (first 1991, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 94 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 5 | 5 |
| BWF | Spirometer, Therapeutic (Incentive) | 3 | 3 |
| BZA | Connector, Airway (Extension) | 3 | 3 |
Review panels
- Anesthesiology (11)
Most recent Dhd Diemolding Healthcare Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973532 | STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR | CAF | 1998-03-19 | 182 |
| K970596 | DHD EMERALD PRODUCT | BWF | 1997-05-16 | 87 |
| K961973 | DHD ACE WITH MASK KIT | CAF | 1996-08-15 | 87 |
| K953206 | DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) | CAF | 1995-08-28 | 90 |
| K945118 | EXPIRATORY BREATHING EXERCISER | BWF | 1995-01-13 | 87 |
| K944900 | THERAPEP | BWF | 1995-01-06 | 94 |
| K926301 | ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO | CAF | 1993-07-21 | 218 |
| K922537 | DURALIFE | BZA | 1992-12-04 | 190 |
| K913726 | DURALIFE(TM) | BZA | 1992-02-07 | 171 |
| K913326 | DHD METERED DOSE INHALER (MDI) SPACER | CAF | 1992-01-07 | 166 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dhd Diemolding Healthcare Div..
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 Diemolding Healthcare Div. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Dhd Diemolding Healthcare Div.?
FDA lists 11 510(k) clearances under the applicant name “Dhd Diemolding Healthcare Div.” (first 1991, latest 1998), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dhd Diemolding Healthcare Div.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dhd Diemolding Healthcare Div. is 94 days.
Which FDA product codes appear under Dhd Diemolding Healthcare Div.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 5); BWF (Spirometer, Therapeutic (Incentive), 3); BZA (Connector, Airway (Extension), 3).
Next steps
- See all 11 Dhd Diemolding Healthcare Div. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Dhd Diemolding Healthcare Div.'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.