Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hpd Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
463 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914994 | HPD HEATER BASES | Hpd Medical, Inc. | 1993-02-12 | 463 | 0 |
| K895795 | HPD TUBING CONNECTORS | Hpd Medical, Inc. | 1990-01-26 | 121 | 0 |
| K885314 | HPD STERILE HUMIDIFYING CHAMBER | Hpd Medical, Inc. | 1989-01-17 | 19 | 0 |
| K864173 | HPD HUMIDIFYING CHAMBER | Hpd Medical, Inc. | 1987-01-30 | 98 | 0 |
| K841851 | HPD HUMIDIFIER WICK | Hpd Medical, Inc. | 1984-06-05 | 33 | 0 |
| K821957 | CATH-LOK | Hpd Medical, Inc. | 1982-07-28 | 28 | 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