Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dynatech Medical Products — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
213 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923187 | IMPERVIOUS ISOLATION SHOE COVERS | Dynatech Medical Products | 1993-01-29 | 213 | 0 |
| K923188 | DYNASTY IMPERVIOUS ISOLATION J-SUIT | Dynatech Medical Products | 1993-01-29 | 213 | 0 |
| K922234 | DYNASTY ISOLATION GOWN | Dynatech Medical Products | 1992-08-11 | 90 | 0 |
| K893520 | DR. BOO LATEX EXAMINATION GLOVES | Dynatech Medical Products | 1989-08-21 | 105 | 0 |
| K770730 | PUMP, INFUSION, DYNATECH/HANDLEY | Dynatech Medical Products | 1977-07-11 | 82 | 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