# K110771: BD Single Use, Hypodermic Syringe

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: May 13, 2011 after 53 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980987 (1998). 1 ancestor in all.
17 later devices descend from it; 9 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.

## Most influential descendants
- K143757: ANUTRA Feedback Aspiration Syringe (2015), 2 descendants of its own
- K132553: U&U Sterile Piston Syringe Without Needle (2014), 2 descendants of its own
- K113241: BD Emerald Single Use, Hypodermic Syringe (2011), 2 descendants of its own
- K201816: Arthrotap (2020), 1 descendant of its own
- K191642: TK Sterile Piston Syringe without Needle (2020), 1 descendant of its own

## Recalls of this device
- Apr 28, 2026 · Class II · Z-2614-2026: A single lot of expired syringes were distributed due to a distribution system control failure.
- Sep 16, 2016 · Class II · Z-2752-2017: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
- Sep 16, 2016 · Class II · Z-2751-2017: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.
- Sep 16, 2016 · Class II · Z-2750-2017: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
- Sep 16, 2016 · Class II · Z-2747-2017: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
- Sep 16, 2016 · Class II · Z-2749-2017: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
- Sep 16, 2016 · Class II · Z-2753-2017: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
- Mar 25, 2016 · Class II · Z-1936-2016: BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conform
- Mar 25, 2016 · Class II · Z-1937-2016: BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conform
- Dec 19, 2014 · Class II · Z-1055-2015: The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

## Indications for use
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

Source page: https://510kreport.com/device/K110771
Methodology: https://510kreport.com/methodology