# K061492: Monoject Magellan Insulin and Tuberculin Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare
- Decided: Aug 3, 2006 after 64 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 K922522 (1992). 1 ancestor in all.
20 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922522: Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes, Sherwood Medical Co. (1992) Summary page 1.

## Most influential descendants
- K132681: Sol-Guard Insulin and Tuberculin Safety Syringe (2014), 16 descendants of its own
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle (2020), 14 descendants of its own
- K210443: PLPT LDV (Low Dead Volume) Sterile Syringe (2021), 6 descendants of its own
- K213010: FEELject LDV (Low dead volume) syringe (2023), 2 descendants of its own
- K231856: TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (2024), 1 descendant of its own

## Indications for use
The device is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks. The device is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

Source page: https://510kreport.com/device/K061492
Methodology: https://510kreport.com/methodology