# K813338: Biopsy Needles & Trays

- Pathway: 510(k) (Traditional)
- Applicant: American Pharmaseal Div. Ahsc
- Decided: Jan 28, 1982 after 65 days
- Product code: FSH (Tray, Surgical, Needle)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- 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
- K961185: Daum Biopsyneedle (1996), 1 descendant 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
- May 21, 2026 · Class II · Z-2668-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Feb 23, 2017 · Class II · Z-1422-2018: The integrity of the sterile packaging is potentially compromised.

Source page: https://510kreport.com/device/K813338
Methodology: https://510kreport.com/methodology