510(k) Report

FDA applicant

In-Line Diagnostics Corp.

Riverdale, UT8 decisions1995–20001 recall

FDA records 8 decisions for In-Line Diagnostics Corp. (Riverdale, UT) from 1995 to 2000: 8 510(k) clearances. Most are in product codes MQS (System, Hemodialysis, Access Recirculation…) and KOC (Accessories, Blood Circuit, Hemodialysis). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided In-Line Diagnostics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for In-Line Diagnostics Corp. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — In-Line Diagnostics Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like In-Line Diagnostics Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQSSystem, Hemodialysis, Access Recirculation Monitoring5decisions
  • KOCAccessories, Blood Circuit, Hemodialysis1decision
  • JPIDevice, Hematocrit Measuring1decision
  • GKFInstrument, Hematocrit, Automated1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K972470Crit-Line Monitor (Clmiii)In-Line Diagnostics Corp. · 19973cite it
  • K982412Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 19982cite it
  • K953875Crit-Line Hematocrit Alert (Modification)In-Line Diagnostics Corp. · 19961cites it
  • K935958Crit-Line Blood Chamber with E-BeamIn-Line Diagnostics Corp. · 19951cites it
  • K950942Crit-Line Hematocrit AlertIn-Line Diagnostics Corp. · 19951cites it

What has FDA decided for it lately?

  • K001763Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 2000
  • K992227Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1999
  • K983551Crit-Scan II MonitorIn-Line Diagnostics Corp. · 1999
  • K982412Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1998
  • K972470Crit-Line Monitor (Clmiii)In-Line Diagnostics Corp. · 1997
  • K953875Crit-Line Hematocrit Alert (Modification)In-Line Diagnostics Corp. · 1996
  • K950942Crit-Line Hematocrit AlertIn-Line Diagnostics Corp. · 1995
  • K935958Crit-Line Blood Chamber with E-BeamIn-Line Diagnostics Corp. · 19951 recall

All 8 as In-Line Diagnostics Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K935958CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood…Apr 27, 2015Class II