Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MQS — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
191 daysmedian FDA review time
531 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023-12-14 | 136 | 0 |
| K180410 | Dosis SAM | Dosis, Inc. | 2019-01-16 | 336 | 0 |
| K130579 | PHYSOFT AMS | Physicians Software Systems, LLC | 2013-12-19 | 289 | 0 |
| K042566 | VASC-ALERT | Vasc-Alert, Inc. | 2004-11-08 | 48 | 0 |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | Transonic Systems, Inc. | 2002-12-04 | 89 | 0 |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | Transonic Systems, Inc. | 2002-08-12 | 90 | 0 |
| K001763 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 2000-12-20 | 191 | 0 |
| K993587 | HP M2376A DEVICE LINK SYSTEM | Hewlett-Packard Co. | 2000-01-20 | 90 | 0 |
| K992227 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1999-07-30 | 28 | 0 |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Hewlett-Packard Co. | 1999-04-30 | 158 | 0 |
| K982412 | MODIFICATION OF CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1998-10-09 | 88 | 0 |
| K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-C | Transonic Systems, Inc. | 1998-10-06 | 210 | 0 |
| K972470 | CRIT-LINE MONITOR (CLMIII) | In-Line Diagnostics Corp. | 1997-12-11 | 163 | 0 |
| K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997-02-11 | 349 | 1 |
| K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR | Cobe Renal Care, Inc. | 1997-02-06 | 531 | 0 |
| K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | In-Line Diagnostics Corp. | 1996-07-23 | 391 | 0 |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | Fresenius USA, Inc. | 1996-07-03 | 831 | 0 |
| K953551 | KNOW-RECIRC | H&H Control Systems | 1996-06-21 | 329 | 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