# K962638: Tonocap, TC-200 and Accessory Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Corp.
- Decided: Apr 4, 1997 after 273 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K984579: Capno Probe a (2000), 1 descendant of its own
- K993656: Datex-Ohmeda Tonometry Module M-Tono (2000), 1 descendant of its own
- K212425: MicroTrend System (2024), 0 descendants of its own
- K052167: Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K962638
Methodology: https://510kreport.com/methodology