# K945677: IL682, CO-Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Oct 20, 1995 after 336 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 3 cite it directly.
0 of 22 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
- K963800: IL Synthesis (1996), 20 descendants of its own
- K992834: Gem Premier 3000 (1999), 18 descendants of its own
- K022158: Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product) (2002), 17 descendants of its own
- K052121: Gem Premier 3000 (2005), 16 descendants of its own
- K061974: Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4 Hematocrit (2006), 14 descendants of its own

Source page: https://510kreport.com/device/K945677
Methodology: https://510kreport.com/methodology