# K992734: Becton Dickinson Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Oct 1, 1999 after 49 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Syringes: named in the summary without a submission number
- (no number) SafetyGlide™ Needle: named in the summary without a submission number

## Most influential descendants
- K050131: Insosafe Bak'snap Retractable Insulin Safety Syringe (2005), 8 descendants of its own
- K152808: U&U Insulin Syringe with/without Safety Retractable Device (2016), 5 descendants of its own
- K202570: Insulin Syringe, Insulin Syringe with Safety Retractable (2021), 2 descendants of its own
- K220061: Safety Insulin Syringes (2022), 1 descendant of its own
- K230061: Insulin Syringe (2023), 0 descendants of its own

## Recalls of this device
- May 1, 2013 · Class II · Z-1577-2013: There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.
- Jul 24, 2006 · Not classified · Z-1525-06: BD received reports of needle assembly disengagement from the syringe.
- Oct 25, 2005 · Not classified · Z-0403-06: Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.
- Oct 25, 2005 · Not classified · Z-0402-06: Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.
- Oct 25, 2005 · Not classified · Z-0404-06: Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.
- Oct 25, 2005 · Not classified · Z-0405-06: Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.

## Indications for use
The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intra-dermal injections. The allergy treatment syringe has a regular bevel which is typically used for subcutaneous injections. The tuberculin syringe has a regular bevel which can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous). The SafetyGlide™ Syringe contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Source page: https://510kreport.com/device/K992734
Methodology: https://510kreport.com/methodology