Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cryomedics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
175 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851152 | MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR | Cryomedics, Inc. | 1985-06-24 | 95 | 0 |
| K844431 | YN CO2 LASER SYSTEM 30W | Cryomedics, Inc. | 1985-02-25 | 101 | 0 |
| K842888 | DUAL CHANNEL TENS, PULSAR REMOTE CONTRL | Cryomedics, Inc. | 1985-01-14 | 175 | 0 |
| K842959 | MC-4000 CONSOLE & PROBES | Cryomedics, Inc. | 1984-12-07 | 133 | 0 |
| K842704 | MT-700 MT-750 FT-350 | Cryomedics, Inc. | 1984-08-01 | 21 | 0 |
| K801730 | KRYMED SYSTEM 4001 TILT SCOPE | Cryomedics, Inc. | 1980-08-13 | 19 | 0 |
| K800335 | KRYMED LIQUID NITROGEN CRYOJET | Cryomedics, Inc. | 1980-04-04 | 50 | 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