Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Holgrath Medical Technologies, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
245 daysmedian FDA review time
245 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954835 | HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET | Holgrath Medical Technologies, Inc. | 1996-01-31 | 103 | 0 |
| K946047 | HOLGRATH METAL-HUB, EPIDURAL NEEDLE | Holgrath Medical Technologies, Inc. | 1995-07-25 | 225 | 0 |
| K944908 | HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE | Holgrath Medical Technologies, Inc. | 1995-06-07 | 245 | 0 |
| K944905 | HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE | Holgrath Medical Technologies, Inc. | 1995-06-07 | 245 | 0 |
| K944907 | HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE | Holgrath Medical Technologies, Inc. | 1995-06-07 | 245 | 0 |
| K944906 | HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE | Holgrath Medical Technologies, Inc. | 1995-06-07 | 245 | 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