Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cybermedic, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
225 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941813 | VENSHIELD | Cybermedic, Inc. | 1994-05-03 | 21 | 0 |
| K914205 | PFF-1 | Cybermedic, Inc. | 1992-05-01 | 225 | 0 |
| K903959 | NEONATAL METASCOPE | Cybermedic, Inc. | 1990-11-23 | 87 | 0 |
| K884910 | MODEL 1010, CY-MET | Cybermedic, Inc. | 1989-06-12 | 199 | 0 |
| K861418 | SPINNAKER | Cybermedic, Inc. | 1986-05-09 | 24 | 0 |
| K851197 | CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH | Cybermedic, Inc. | 1985-07-08 | 104 | 0 |
| K842782 | PHYSIOLOGICAL ANALYZER CM-710 | Cybermedic, Inc. | 1984-08-17 | 31 | 0 |
| K842760 | LUNG ANALYZER CM-310 | Cybermedic, Inc. | 1984-07-26 | 10 | 0 |
| K831586 | CM-VII PHYSIOLOGIC ANALYZER | Cybermedic, Inc. | 1984-03-19 | 307 | 0 |
| K800547 | MEDISTOR III LUNG ANALYZER | Cybermedic, Inc. | 1980-03-25 | 15 | 0 |
| K790579 | MEDISTOR II | Cybermedic, Inc. | 1979-04-04 | 8 | 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