# K923127: Needle-Pro Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Concord/Portex
- Decided: Apr 29, 1993 after 307 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904198 (1990). 1 ancestor in all.
84 later devices descend from it; 3 cite it directly.
1 of 86 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904198: Safety Needle Sheath, Concord/Portex (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K854597: Vickers Medical Model 271 Heart Rate Monitor, Vickers, Ltd. (1986). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K031453: Terumo Surguard 2 Safety Needle (2003), 74 descendants of its own
- K040531: Terumo SURGUARD2 Safety Needle (2004), 67 descendants of its own
- K051865: Terumo Surguard 2 Safety Needle or Similar (2005), 65 descendants of its own
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle (2012), 60 descendants of its own
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (2017), 32 descendants of its own

## Recalls of this device
- Apr 4, 2017 · Class II · Z-2670-2017: Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smith

## Indications for use
To inject into or withdraw fluids from, parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K923127
Methodology: https://510kreport.com/methodology