# K012726: Prosafe Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Hou-Se Medical, Inc.
- Decided: Oct 18, 2001 after 64 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) B-D Luer Lok syringe: named in the summary without a submission number
- (no number) Retractable Technology, Inc. VanishPoint syringe: named in the summary without a submission number

## Most influential descendants
- K052397: Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML) (2005), 3 descendants of its own
- K060208: Careo Safety Syringe 1CC/ML, Models CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C, (2006), 2 descendants of its own
- K061055: Careo Safety Syringe for U-100 Insulin (2006), 1 descendant of its own
- K072037: Careo Safety Syringe for U-100 Insulin 0.5CC/ML (2007), 0 descendants of its own
- K031830: Safepro Plus Safety Syringe (2003), 0 descendants of its own

## Indications for use
A properly placed syringe provides access to a vein or tissue for fluid sampling or infusion. The safety syringe is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a needle retraction system which is activated after the infusion procedure is completed.

Source page: https://510kreport.com/device/K012726
Methodology: https://510kreport.com/methodology