Dhd Medical Products Div. Diemolding Corp.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Dhd Medical Products Div. Diemolding Corp.” (first 1979, latest 1988), across 19 product codes in 2 review panels. Median 510(k) review time under this name: 23 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | 8 | 8 |
| BYH | Drain, Tee (Water Trap) | 5 | 5 |
| BWF | Spirometer, Therapeutic (Incentive) | 4 | 4 |
| BYG | Mask, Oxygen | 3 | 3 |
| CBT | Arterial Blood Sampling Kit | 3 | 3 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| CBP | Valve, Non-Rebreathing | 2 | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 | 2 |
Plus 9 more product codes.
Review panels
- Anesthesiology (40)
- Ear, Nose and Throat (1)
Most recent Dhd Medical Products Div. Diemolding Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883988 | NON-REBREATHING TEE PIECE (NRTP) | CBP | 1988-10-07 | 17 |
| K881935 | MICROCIRRUS MEDICAL NEBULIZER | CAF | 1988-06-22 | 44 |
| K881178 | CUFFCHECK | BSK | 1988-04-14 | 27 |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | BXR | 1988-03-09 | 191 |
| K874047 | ASTHMAKIT | CAF | 1988-02-29 | 147 |
| K873447 | DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR | BYH | 1987-10-30 | 74 |
| K860885 | STRAIGHT CONNECTORS, 15MM, 30MM & 19MM | BZA | 1986-03-20 | 23 |
| K860882 | DISPOSABLE CATHETER | BZA | 1986-03-20 | 23 |
| K860880 | VENTILATOR CIRCUITS (VARIOUS TYPES) | BZO | 1986-03-20 | 23 |
| K860879 | DISPOSABLE VENTILATOR CIRCUITS | BZO | 1986-03-20 | 23 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dhd Medical Products Div. Diemolding 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 Medical Products Div. Diemolding Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Dhd Medical Products Div. Diemolding Corp.?
FDA lists 43 510(k) clearances under the applicant name “Dhd Medical Products Div. Diemolding Corp.” (first 1979, latest 1988), across 19 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 Medical Products Div. Diemolding Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dhd Medical Products Div. Diemolding Corp. is 23 days.
Which FDA product codes appear under Dhd Medical Products Div. Diemolding Corp.?
The most frequent FDA product codes under this applicant name are BZA (Connector, Airway (Extension), 8); BYH (Drain, Tee (Water Trap), 5); BWF (Spirometer, Therapeutic (Incentive), 4).
Next steps
- See all 43 Dhd Medical Products Div. Diemolding Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZA, Dhd Medical Products Div. Diemolding 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.