# K023752: BD Integra Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bd
- Decided: Feb 7, 2003 after 91 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980069 (1998). 3 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980580: Becton Dickinson Syringes, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K011103: BD Spring Based Syringe, Bd (2001)
- K980069: Vanishpoint Syringe, Retractable Technologies, Inc. (1998) Summary page 1.

## Most influential descendants
- K132120: WTF Secura Syringe and Needle (2013), 5 descendants of its own
- K182274: Orbit Subretinal Delivery System (2018), 4 descendants of its own
- K200325: Orbit Subretinal Delivery System (2020), 3 descendants of its own
- K143497: Safety Auto-Disable Syrine with Needle (Auto-Lock) (2015), 3 descendants of its own
- K203264: MicroDose Injector (2021), 2 descendants of its own

## Recalls of this device
- Nov 24, 2008 · Not classified · Z-0619-2009: Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.
- Jan 27, 2007 · Not classified · Z-0582-2007: The needle becomes detached from the hub/syringe

## Indications for use
The BD IntegraTM Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy. The insulin syringe has scale lines in insulin units and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous). The BD IntegraTMlml Syringe has a permanently attached needle. The BD IntegraTM1nil Syringe contains a tool used to cut through the hub and stopper allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needlehyringe combination.

Source page: https://510kreport.com/device/K023752
Methodology: https://510kreport.com/methodology