# K121599: Crit-Line Clip (Clic)

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care-North America
- Decided: Nov 9, 2012 after 161 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972470 (1997). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972470: Crit-Line Monitor (Clmiii), In-Line Diagnostics Corp. (1997) Summary page 1.

## Most influential descendants
- K131908: 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) (2013), 10 descendants of its own
- K150708: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (2015), 9 descendants of its own
- K153449: 2008K2 Hemodialysis Machine (2016), 8 descendants of its own
- K173972: 2008T BlueStar Hemodialysis Machine (2018), 7 descendants of its own
- K231125: 2008T BlueStar Hemodialysis Machine (2023), 4 descendants of its own

## Recalls of this device
- May 24, 2016 · Class II · Z-2044-2016: Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.

## Indications for use
The Crit-Line Clip monitor (CLIC) is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. CLiC measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

Source page: https://510kreport.com/device/K121599
Methodology: https://510kreport.com/methodology