Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
In-Line Diagnostics Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
419 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001763 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 2000-12-20 | 191 | 0 |
| K992227 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1999-07-30 | 28 | 0 |
| K983551 | CRIT-SCAN II MONITOR | In-Line Diagnostics Corp. | 1999-05-27 | 230 | 0 |
| K982412 | MODIFICATION OF CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1998-10-09 | 88 | 0 |
| K972470 | CRIT-LINE MONITOR (CLMIII) | In-Line Diagnostics Corp. | 1997-12-11 | 163 | 0 |
| K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | In-Line Diagnostics Corp. | 1996-07-23 | 391 | 0 |
| K950942 | CRIT-LINE HEMATOCRIT ALERT | In-Line Diagnostics Corp. | 1995-03-14 | 27 | 0 |
| K935958 | CRIT-LINE BLOOD CHAMBER WITH E-BEAM | In-Line Diagnostics Corp. | 1995-01-19 | 419 | 1 |
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