Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sancella, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
156 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911944 | MEDI GUARD DENTAL BIB | Sancella, Inc. | 1991-10-04 | 156 | 0 |
| K911948 | MEDI GUARD PILLOWCASE | Sancella, Inc. | 1991-05-28 | 27 | 0 |
| K911952 | MEDI GUARD UNDERPAD | Sancella, Inc. | 1991-05-28 | 27 | 0 |
| K911953 | MEDI GUARD SHEETS/UNDERLAYS | Sancella, Inc. | 1991-05-28 | 27 | 0 |
| K911950 | MEDI GUARD DRAPES | Sancella, Inc. | 1991-05-21 | 20 | 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