# K834208: Colloid Osmometer 4400

- Pathway: 510(k) (Traditional)
- Applicant: Wescor, Inc.
- Decided: Mar 23, 1984 after 109 days
- Product code: JJM (Osmometer For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2730
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 26, 2007 · Not classified · Z-1351-2008: Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
- Dec 26, 2007 · Not classified · Z-1350-2008: Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.

Source page: https://510kreport.com/device/K834208
Methodology: https://510kreport.com/methodology