# K935958: Crit-Line Blood Chamber with E-Beam

- Pathway: 510(k) (Traditional)
- Applicant: In-Line Diagnostics Corp.
- Decided: Jan 19, 1995 after 419 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K141281: Crit-Line Clip (Clic) Blood Chamber (2014), 7 descendants of its own
- K152953: Crit-Line Clip (Clic) Blood Chamber (2015), 6 descendants of its own
- K201207: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (2020), 5 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own

## Recalls of this device
- Apr 27, 2015 · Class II · Z-1716-2015: Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber

Source page: https://510kreport.com/device/K935958
Methodology: https://510kreport.com/methodology