# K924167: Crit-Line

- Pathway: 510(k) (Traditional)
- Applicant: Noninvasive Medical Technology Corp.
- Decided: May 7, 1993 after 261 days
- Product code: JPI (Device, Hematocrit Measuring)
- Device class: 2
- Regulation: 21 CFR 864.6400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970446: Drake Willock System & Altra Touch 1000 Dialysis Delivery System (1997), 11 descendants of its own
- K993064: Prisma CFM (Continuous Fluid Management System) (1999), 9 descendants of its own
- K021615: Baxter Accura System, Model 5M5660 (2002), 8 descendants of its own
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets (2004), 4 descendants of its own
- K080519: Prismaflex M150 Set (2008), 1 descendant of its own

Source page: https://510kreport.com/device/K924167
Methodology: https://510kreport.com/methodology