Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healthtek, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
379 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923448 | EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG | Healthtek, Inc. | 1993-07-28 | 379 | 0 |
| K913985 | TRANSFER-AID(TM) | Healthtek, Inc. | 1992-03-18 | 195 | 0 |
| K913608 | SNAPPER | Healthtek, Inc. | 1991-11-29 | 107 | 0 |
| K881590 | ADFUSE(TM) | Healthtek, Inc. | 1988-05-23 | 40 | 0 |
| K874495 | ADCOMP 4000 HP SYSTEM | Healthtek, Inc. | 1988-02-16 | 106 | 0 |
| K873848 | RETROBULBAR NEEDLE | Healthtek, Inc. | 1987-10-23 | 31 | 0 |
| K860610 | ADCOMP | Healthtek, Inc. | 1986-07-08 | 139 | 0 |
| K860372 | FAST FLOW XX (AQUEOUS SOLUTION FILTER) | Healthtek, Inc. | 1986-05-30 | 116 | 0 |
| K854008 | STATLOCK | Healthtek, Inc. | 1985-11-13 | 44 | 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