# K971487: Bkmi Disposable Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sumi Salud C.A.
- Decided: Sep 4, 1997 after 134 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
BKMT’s Disposable Syringes, with or without attached BKMI disposable single lumen hypodermic needles, are intended to be sterile, single use, disposable, nonpyrogenic, nontoxic, calibrated, piston syringes intended for injecting fluids into, or withdrawing fluids out of, the body via a single lumen stainless steel hypodermic needle.

Source page: https://510kreport.com/device/K971487
Methodology: https://510kreport.com/methodology