# K854547: Monoject Sterile M200 Aluminum/M250 Polypropylene

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Feb 4, 1986 after 83 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K964654: Becton Dickinson Blunt Plastic Cannula (1997), 2 descendants of its own
- K974363: Becton Dickinson Blunt Plastic Cannula (1998), 1 descendant of its own
- K101309: Exelint Aluminum Hub Blunt Needles (2010), 0 descendants of its own
- K073122: Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle (2007), 0 descendants of its own
- K013949: Universal Vial Access Spike with Needleless Connector (2002), 0 descendants of its own

## Recalls of this device
- Sep 25, 2020 · Class II · Z-0424-2021: Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause th
- Apr 30, 2019 · Class II · Z-2043-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2044-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2049-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2048-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2042-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2038-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2047-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2036-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2052-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2040-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2051-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2037-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2041-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2046-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2050-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2039-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Apr 30, 2019 · Class II · Z-2045-2019: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Source page: https://510kreport.com/device/K854547
Methodology: https://510kreport.com/methodology