510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946170Substantially Equivalent

Comfort-Q Subcutaneous Injection Sets

B. Braun of America, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946170 is the FDA 510(k) clearance record for COMFORT-Q SUBCUTANEOUS INJECTION SETS, a class II device, cleared for B. Braun of America, Inc. on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list 19 510(k) clearances for B. Braun of America, Inc., from to . As of , FDA records show no recalls naming K946170.

Clearance record

Decision date
Received
(319 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
B. Braun of America, Inc. 824 Twelfth Ave., Bethlehem PA
510(k) summary
Summary
Third party review
No

Clearances, product code FOZ

Trailing 12 months
9 clearances under product code FOZ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260