Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cryodyne Technologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
243 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926464 | L.C.S.3000 | Cryodyne Technologies, Inc. | 1993-08-24 | 243 | 0 |
| K932520 | CALIBRATION GAS | Cryodyne Technologies, Inc. | 1993-08-19 | 86 | 0 |
| K881465 | CRYOBIOLOGICAL FREEZER | Cryodyne Technologies, Inc. | 1988-04-21 | 15 | 0 |
| K881466 | CELL-CULTURE SHAKER | Cryodyne Technologies, Inc. | 1988-04-18 | 12 | 0 |
| K881467 | MICROSCOPE STAGE HEATER | Cryodyne Technologies, Inc. | 1988-04-18 | 12 | 0 |
| K860738 | CTC 30, 40, 1 LIQUID OXYGEN LITERS | Cryodyne Technologies, Inc. | 1986-08-06 | 160 | 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