# K971924: Blunt Syringe Cannula

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Sep 25, 1998 after 490 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
Longest line of descent: 1 generation back to K920422 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920422: B-D Interlink Syringe Cannula, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 1.

## Cited in the summary but kept off the family tree
- K913177: Solcotrans Orthopaedic Drainage/Reinfusion System, Solco Basle, Inc. (1993). Our OCR of the scanned summary read K913177, FDA’s number for Solcotrans Orthopaedic Drainage/Reinfusion System (Solco Basle, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SafeLine System”. Kept off the family tree. Summary page 1.

## Indications for use
to be used with a syringe to pierce a pre-split rubber injection site.

Source page: https://510kreport.com/device/K971924
Methodology: https://510kreport.com/methodology