# K854095: Biopsy Tray I & II

- Pathway: 510(k) (Traditional)
- Applicant: North Coast Medi-Tek
- Decided: Nov 25, 1985 after 49 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 3 (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
- May 13, 2011 · Not classified · Z-2982-2011: During routine bioburden testing, unusually high results were found for a Bioburden Test done on 4/19/11. Bioburden Level reported as >150,000 CFU. Our Alert Level is 17,000 CFU and the Action Level i
- Jan 18, 2005 · Not classified · Z-1572-05: Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies 
- Jun 23, 2004 · Not classified · Z-1523-05: Product contains the incorrect lot number.

Source page: https://510kreport.com/device/K854095
Methodology: https://510kreport.com/methodology