510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K973654Substantially Equivalent

Vial-Mate Reconstitution Device (2B8071)

Baxter Healthcare Corporation, Round Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973654 is the FDA 510(k) clearance record for VIAL-MATE RECONSTITUTION DEVICE (2B8071), a class II device, cleared for Baxter Healthcare Corp on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show one recall naming K973654.

Clearance record

Decision date
Received
(29 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Baxter Healthcare Corp Rte. 120 And Wilson Rd., Round Lake IL
510(k) summary
Summary
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260