Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carroll Biological Corp. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
66 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832243 | CULTURE MEDIUM FOR ANTIMICROBIAL SUS | Carroll Biological Corp. | 1983-09-29 | 83 | 0 |
| K832620 | TRYPTIC SOY BROTH MEDIA | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832617 | XYLOSE LYSINE DEOXYCHOLATE | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832614 | SELENITE BROTH | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832616 | MACCONKEY AGAR MEDIA | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832618 | BLUE AGAR | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832611 | TRYPTIC SOY AGAR | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832613 | MANNITOL SALT AGAR | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832615 | SF BROTH | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832619 | THIOGLYCOLLATE MEDIUM | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K832612 | CHOCOLATE AGAR & THAYER MARTIN AGAR | Carroll Biological Corp. | 1983-09-12 | 66 | 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