# K012121: Secureguard Retractable Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Safegard Medical Products, Inc.
- Decided: Oct 24, 2001 after 110 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SOLOGARD® Locking Plus Syringe: named in the summary without a submission number

## Most influential descendants
- K031594: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray (2003), 15 descendants of its own
- K050131: Insosafe Bak'snap Retractable Insulin Safety Syringe (2005), 8 descendants of its own
- K152808: U&U Insulin Syringe with/without Safety Retractable Device (2016), 5 descendants of its own
- K042500: Duopross Syringes (2005), 4 descendants of its own
- K030976: Careo Retractable Safety Syringe (2003), 4 descendants of its own

## Recalls of this device
- May 10, 2010 · Not classified · Z-1800-2010: Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification.

## Indications for use
The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

Source page: https://510kreport.com/device/K012121
Methodology: https://510kreport.com/methodology