Hpd Medical, Inc.: FDA clearances and approvals
Hpd Medical, Inc. has 6 FDA 510(k) clearances (first 1982, latest 1993), across 4 product codes in 3 review panels. Median 510(k) review time: 66 days.
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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 3 | 3 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
Review panels
- Anesthesiology (4)
- Cardiovascular (1)
- General Hospital (1)
Most recent Hpd Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914994 | HPD HEATER BASES | BZE | 1993-02-12 | 463 |
| K895795 | HPD TUBING CONNECTORS | DTL | 1990-01-26 | 121 |
| K885314 | HPD STERILE HUMIDIFYING CHAMBER | BTT | 1989-01-17 | 19 |
| K864173 | HPD HUMIDIFYING CHAMBER | BTT | 1987-01-30 | 98 |
| K841851 | HPD HUMIDIFIER WICK | BTT | 1984-06-05 | 33 |
| K821957 | CATH-LOK | KMK | 1982-07-28 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Hpd Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hpd Medical, Inc. have?
Hpd Medical, Inc. has 6 FDA 510(k) clearances (first 1982, latest 1993), across 4 product codes in 3 review panels.
How long does FDA take to clear Hpd Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hpd Medical, Inc.'s cleared 510(k)s is 66 days.
What devices does Hpd Medical, Inc. make?
Its most frequent FDA product codes are BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 3); BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, 1); DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 1).
Has Hpd Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hpd Medical, Inc. Related entities may recall under other names.
Next steps
- See all 6 Hpd Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTT, Hpd Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.