510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853418Substantially Equivalent

Safti-Bracelet

Advanced Biosearch Assn., Danville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853418 is the FDA 510(k) clearance record for SAFTI-BRACELET, a class I device, cleared for Advanced Biosearch Assn. on under FDA product code KMK (Device, Intravascular Catheter Securement). FDA records list 22 510(k) clearances for Advanced Biosearch Assn., from to . As of , FDA records show no recalls naming K853418.

Clearance record

Decision date
Received
(37 days to decision)
Product code
KMK Device, Intravascular Catheter Securement
Regulation
21 CFR 880.5210
Device class
Class I
Review panel
General Hospital
Applicant
Advanced Biosearch Assn. 3880 Blackhawk Rd., Danville CA
Third party review
No

Clearances, product code KMK

Trailing 12 months

FDA records hold no clearances under product code KMK in the trailing twelve months.

FDA records show no clearances under product code KMK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260