# K993017: Profi Disposable Syringe, Profi Disposable Needle, DM Ject Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Shinchang Medical Co., Ltd.
- Decided: Feb 25, 2000 after 170 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123710: Unitox Botox Syringe (2013), 1 descendant of its own
- K212677: aboNT SYRINGE (2022), 0 descendants of its own

## Recalls of this device
- Sep 4, 2018 · Class II · Z-0119-2019: Small hole at the end of the syringe is impeding suction of liquid.
- Aug 24, 2018 · Class II · Z-3202-2018: Defect consists of a small crack in the top end of the barrel near the needle.
- Oct 27, 2009 · Not classified · Z-0573-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0570-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0571-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0574-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0569-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0572-2010: Needles are becoming dislodged from the barrels

## Indications for use
Hypodermic single lumen needle: Device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Piston Syringe: Device is used to inject fluids into, or withdraw fluids from the body. Diabetic Insulin Syringe: Device intended to inject insulin below the surface of the skin.

Source page: https://510kreport.com/device/K993017
Methodology: https://510kreport.com/methodology