# K854762: Hepanorm Calibration Plasma Set

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Mar 3, 1986 after 96 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K111822: Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH (2011), 1 descendant of its own
- K260214: STA® - Liquid Anti-Xa (2026), 0 descendants of its own
- K092937: Sta-Hybrid Hep Calibrator (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K854762
Methodology: https://510kreport.com/methodology