Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Scientific, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
256 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071832 | MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | 2007-09-18 | 77 | 0 |
| K063700 | SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | 2007-02-08 | 57 | 0 |
| K031564 | CSS | Medical Scientific, Inc. | 2003-10-07 | 141 | 0 |
| K011202 | MSI BIPOLAR SHEATH | Medical Scientific, Inc. | 2001-12-31 | 256 | 0 |
| K981387 | EVANESCE SCAR MANAGEMENT SYSTEM | Medical Scientific, Inc. | 1998-06-10 | 55 | 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