510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K131692Substantially Equivalent

Blossom Saline Delivery Assist Device

Marz Medical, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131692 is the FDA 510(k) clearance record for BLOSSOM SALINE DELIVERY ASSIST DEVICE, cleared for Marz Medical, Inc. on under FDA product code LCJ (Tissue Expander And Accessories). FDA records list one 510(k) clearance for Marz Medical, Inc. As of , FDA records show no recalls naming K131692.

Clearance record

Decision date
Received
(395 days to decision)
Product code
LCJ Tissue Expander And Accessories
Device class
Unclassified
Review panel
Unknown
Applicant
Marz Medical, Inc. 2500 Hospital Dr., Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCJ

Trailing 12 months
1 clearance under product code LCJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LCJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260