# K991758: Monoject Insulin Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: The Kendal Co.
- Decided: Jun 14, 1999 after 21 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851090 (1985). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851090: Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee, Sherwood Medical Co. (1985) Summary page 1.
- K922522: Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes, Sherwood Medical Co. (1992) Summary page 1.
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 1.
- K980580: Becton Dickinson Syringes, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.

## Most influential descendants
- 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

## Indications for use
MONOIJECT Insulin Syringes are used for subcutaneous injection of U-100 Insulin.

Source page: https://510kreport.com/device/K991758
Methodology: https://510kreport.com/methodology