# K983551: Crit-Scan II Monitor

- Pathway: 510(k) (Traditional)
- Applicant: In-Line Diagnostics Corp.
- Decided: May 27, 1999 after 230 days
- Product code: GKF (Instrument, Hematocrit, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910077 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910077: Crit-Scan, Noninvasive Medical Technology Corp. (1992) Summary page 1.

## Indications for use
The intended use of the CRIT-SCAN II Monitor is as a hematocrit-measuring device. NOTE: The CRIT-SCAN II is not for pediatric use,

Source page: https://510kreport.com/device/K983551
Methodology: https://510kreport.com/methodology