Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bib, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
126 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830916 | VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR | Bib, Inc. | 1983-07-07 | 107 | 0 |
| K801389 | BARO/TRAC II & VITA/TRAC, VITAL SIGN MON | Bib, Inc. | 1980-07-28 | 45 | 0 |
| K801366 | DISPOSABLE TEMPERATURE PROBE COVER | Bib, Inc. | 1980-07-28 | 48 | 0 |
| K800596 | VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR | Bib, Inc. | 1980-07-21 | 126 | 0 |
| K800782 | PACE-PULSE/COMPUTRAC | Bib, Inc. | 1980-05-28 | 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