Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medivision Scope Service Center, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
93 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984434 | MEDIVISION LAPAROSCOPE | Medivision Scope Service Center, Inc. | 1999-03-17 | 93 | 0 |
| K982659 | MEDIVISION HYSTEROSCOPE | Medivision Scope Service Center, Inc. | 1998-10-07 | 69 | 0 |
| K982620 | MEDIVISION CYSTOSCOPE | Medivision Scope Service Center, Inc. | 1998-09-30 | 65 | 0 |
| K971996 | MEDIVISION ARTHROSCOP | Medivision Scope Service Center, Inc. | 1997-07-31 | 62 | 0 |
| K971995 | MEDIVISION SINOSCOPE | Medivision Scope Service Center, Inc. | 1997-06-26 | 27 | 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