510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955727Substantially Equivalent

Band-It 20Cc Driver/ 15 Min 20Cc Administration Set

Halyard Health, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955727 is the FDA 510(k) clearance record for BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET, a class II device, cleared for I-Flow Corp. on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list 96 510(k) clearances for Halyard Health, from to . As of , FDA records show no recalls naming K955727.

Clearance record

Decision date
Received
(52 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
I-Flow Corp. 2532 White Rd., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code MEB

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