# K131692: Blossom Saline Delivery Assist Device

- Pathway: 510(k) (Traditional)
- Applicant: Marz Medical, Inc.
- Decided: Jul 10, 2014 after 395 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- 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 K853014 (1985). 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)
- K853014: Mcghan Tissue Expander Fill Kit, Mcghan Medical Corp. (1985) Summary page 1.

## Indications for use
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.

Source page: https://510kreport.com/device/K131692
Methodology: https://510kreport.com/methodology