# K821814: Hemo-Nate L-P Kit

- Pathway: 510(k) (Traditional)
- Applicant: Int'L Corp.
- Decided: Jul 9, 1982 after 21 days
- Product code: KDD (Kit, Surgical Instrument, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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.
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
- Oct 16, 2015 · Class II · Z-0233-2016: Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG

Source page: https://510kreport.com/device/K821814
Methodology: https://510kreport.com/methodology