510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942988Substantially Equivalent

Filtered Extension Sets

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

K942988 is the FDA 510(k) clearance record for FILTERED EXTENSION SETS, a class II device, cleared for B. Braun of America, Inc. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 19 510(k) clearances for B. Braun of America, Inc., from to . As of , FDA records show 31 recalls naming K942988.

Clearance record

Decision date
Received
(389 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
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 FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260