# K913306: Bone-Temno/Sternum-Temno

- Pathway: 510(k) (Traditional)
- Applicant: Proact, Ltd.
- Decided: Nov 1, 1991 after 99 days
- Product code: LWE (Bone Marrow Collection/Transfusion Kit)
- Device class: 2
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K171531: Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle (2017), 3 descendants of its own
- K242322: Bone Marrow Biopsy Needle (2025), 0 descendants of its own
- K192099: MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System (2020), 0 descendants of its own
- K190177: J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, (2019), 0 descendants of its own

## Recalls of this device
- Aug 24, 2021 · Class II · Z-0154-2022: Due to misbranded products shipped to customers.
- Feb 23, 2017 · Class II · Z-1423-2018: The integrity of the sterile packaging is potentially compromised.
- Feb 23, 2017 · Class II · Z-1425-2018: The integrity of the sterile packaging is potentially compromised.
- Feb 23, 2017 · Class II · Z-1424-2018: The integrity of the sterile packaging is potentially compromised.
- Oct 18, 2010 · Not classified · Z-0590-2011: Outer cartons for the product may be labeled with incorrect needle gauge.

Source page: https://510kreport.com/device/K913306
Methodology: https://510kreport.com/methodology