# K990831: Superguard Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Safety Syringes Co., Inc.
- Decided: Mar 8, 2000 after 362 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: 1 generation back to K920321 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920321: Becton Dickinson Safety-Lok Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 1.
- K924072: Becton Dickinson Safety-Lok Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 1.
- (no number) Becton Dickinson Plastipak® (pre-amendment): named in the summary without a submission number

## Indications for use
The SuperGuard™ Safety Syringe is intended as a sterile, single use, disposable syringe, employing an antistick device, for use in the administration of intramuscular and subcutaneous injections.

Source page: https://510kreport.com/device/K990831
Methodology: https://510kreport.com/methodology