# K993125: Safetytip Multi-Sample Needle, Safetytip Blood Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Safety Medical Supply Int,., Inc.
- Decided: Jun 20, 2000 after 274 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Bio-Plexus “Punctur-Guard”: named in the summary without a submission number
- (no number) Sherwood “Monoject”: named in the summary without a submission number
- (no number) Becton Dickinson “Vacutainer”: named in the summary without a submission number
- (no number) Bio-Plexus “Standard Needle Holder”: named in the summary without a submission number
- (no number) Sage “Blood Needle Holder System”: named in the summary without a submission number
- (no number) Becton Dickinson “Safety-Lok Needle”: named in the summary without a submission number

## Indications for use
The SafetyTip™ Blood Collection System is to be used for venous blood collection. The safety sheath helps to prevent accidental needlesticks by sheathing the needle before and after use.

Source page: https://510kreport.com/device/K993125
Methodology: https://510kreport.com/methodology