510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203193Substantially Equivalent

BD Intraosseous Infusion System

Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of BD], Salt Lake Ciy, UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203193 is the FDA 510(k) clearance record for BD Intraosseous Infusion System, a class II device, cleared for Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] on under FDA product code MHC (Needle, Interosseous). FDA records list one 510(k) clearance for Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. As of , FDA records show 2 recalls naming K203193.

Clearance record

Decision date
Received
(127 days to decision)
Product code
MHC Needle, Interosseous
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] 605 N. 5600 W., Salt Lake Ciy, UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MHC

Trailing 12 months

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

FDA records show no clearances under product code MHC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MHC, 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