# K951254: Safetyglide Needle

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Oct 7, 1995 after 200 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
114 later devices descend from it; 8 cite it directly.
3 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972527: Phaseal, System for Sealed Handling of Chemotherapeutic Agents (1997), 56 descendants of its own
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro (1998), 49 descendants of its own
- K023747: Phaseal (2002), 38 descendants of its own
- K110023: Infusion Adapter C100 (2011), 37 descendants of its own
- K092782: Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35, (2009), 36 descendants of its own

## Recalls of this device
- Jul 28, 2020 · Class II · Z-2889-2020: Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially pr
- Jul 5, 2017 · Class II · Z-0315-2018: Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to no
- Jun 13, 2017 · Class II · Z-3116-2017: Presence of loose polypropylene foreign matter above release specification.
- Sep 16, 2016 · Class II · Z-2748-2017: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Source page: https://510kreport.com/device/K951254
Methodology: https://510kreport.com/methodology