VIAL-MATE RECONSTITUTION DEVICE (2B8071)— 510(k) K973654

Name: FDA 510(k) clearance K973654
Creator: U.S. Food and Drug Administration
Published: 1997-10-24

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K973654 for VIAL-MATE RECONSTITUTION DEVICE (2B8071), Substantially Equivalent on 1997-10-24. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1997-09-25
Decision date: 1997-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K973654

K-number listed on FDA's recall record

Z-0392-2014 — Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.Class II·Terminated·Baxter Healthcare Corp.·20130925

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973654.

Data sourced from openFDA. This site is unofficial and independent of the FDA.