# K851090: Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Apr 12, 1985 after 25 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.
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
- K991758: Monoject Insulin Syringe (1999), 3 descendants of its own
- K180683: Certa Dose Pediatric Midazolam 5mg/mL IM Syringe (2018), 0 descendants of its own
- K160589: Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe (2017), 0 descendants of its own
- K081547: Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC (2008), 0 descendants of its own
- K033373: Monoject Insulin Syringe (2003), 0 descendants of its own

## Recalls of this device
- Feb 27, 2026 · Class II · Z-1768-2026: The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin s

Source page: https://510kreport.com/device/K851090
Methodology: https://510kreport.com/methodology