Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Dynatech Cryomedical Co. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
12 daysmedian FDA review time
18 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K771898 | AUTOMATED SLIDE SPINNER | Dynatech Cryomedical Co. | 1977-10-18 | 12 | 0 |
| K771815 | SIGMOSCOPE | Dynatech Cryomedical Co. | 1977-10-07 | 10 | 0 |
| K770896 | COLPOSCOPE MODEL II | Dynatech Cryomedical Co. | 1977-06-03 | 18 | 0 |
| K770614 | MONITOR, GAS MANIFOLD | Dynatech Cryomedical Co. | 1977-04-07 | 7 | 0 |
| K761205 | DYNATECH JD7/JD7P COLPOSCOPE | Dynatech Cryomedical Co. | 1976-12-17 | 10 | 0 |
| K760763 | COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I | Dynatech Cryomedical Co. | 1976-10-20 | 16 | 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