# K141464: Novaguard S a Safety System

- Pathway: 510(k) (Traditional)
- Applicant: West Pharmaceutical Services
- Decided: Sep 10, 2014 after 99 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011369 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123743: Ultrasafe Plus Passive Needle Guard, Safety Syringes, Inc. (2013) Summary page 5.
- K101233: Safe'n'sound Passive Delivery System, Rexam Pharma (2011) Summary page 5.

## Most influential descendants
- K163511: NovaGuard SA Pro Safety System (2017), 0 descendants of its own

## Indications for use
Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Source page: https://510kreport.com/device/K141464
Methodology: https://510kreport.com/methodology