# K821537: Henke Disposable Syringe

- Pathway: 510(k) (Traditional)
- Applicant: C. B. Dumont Company, Inc.
- Decided: May 28, 1982 after 4 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K101547: Henke- Sass, Wolf Piston Syringe (Norm-Jet) (2010), 3 descendants of its own
- K202432: MiniLoad Syringe (2021), 2 descendants of its own
- K231558: SMB Luer lock disposable syringe (2024), 0 descendants of its own
- K212544: MiniLoad Syringe (2021), 0 descendants of its own

## Recalls of this device
- Jul 27, 2023 · Class II · Z-2642-2023: Sterile barrier might be damaged compromising the sterility of the device.

Source page: https://510kreport.com/device/K821537
Methodology: https://510kreport.com/methodology