510(k) · Cleared
ClearedCrit-Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noninvasive Medical Technology Corp. · JPI Device, Hematocrit Measuring
Cleared on May 7, 1993 after a 261-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- May 7, 1993
- Review
- 261 days
- Class
- Class II
- Product code
- JPI
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK924167 Crit-LineNoninvasive Medical Technology Corp. · 1993
- Descendant · cites it directly · 11 of its ownK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
- Descendant · 2 generations on · 9 of its ownK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
- Descendant · 3 generations on · 8 of its ownK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
- Descendant · 4 generations on · 4 of its ownK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled
- Descendant · 5 generations on · 1 of its ownK080519 Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K970446Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · cites it directly11descendants
- K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · 2 generations on9descendants
- K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · 3 generations on8descendants
- K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · 4 generations on4descendants
- K080519Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924167 | Crit-Line | Noninvasive Medical Technology Corp. | 1993 | — |
| +1 | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1997 | 5 |
| +2 | K993064 | Prisma CFM (Continuous Fluid Management System) | Gambro Renal Care Products | 1999 | 1 |
| +3 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 3 |
| +4 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 7 |
| +5 | K080519 | Prismaflex M150 Set | Gambro Renal Products, Inc. | 2008 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JPI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JPI device
- #1 K183680 i-STAT CHEM8+ cartridge with the i-STAT 1 Systemscore 2.5 · 3 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | 1997 | 11 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K970446 (Althin Medical AB an Affiliate of Baxter Intl, 1997) has gone furthest, with 11 descendants of its own.
How does its category compare?
All JPI devicesJPI Device, Hematocrit Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JPI
Too few JPI 510(k)s in any year since 2007 to give a median.
Recalls per year · JPI
8in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPI
34in 2025
MAUDE reports naming product code JPI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 8 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K924167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K924167: Crit-Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K924167
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026