DUAL CHAMBER MIXING BAG— 510(k) K926123

Name: FDA 510(k) clearance K926123
Creator: U.S. Food and Drug Administration
Published: 1993-09-03

Substantially Equivalent

Secure Medical, Inc.

FDA 510(k) clearance K926123 for DUAL CHAMBER MIXING BAG, Substantially Equivalent on 1993-09-03. Applicant: Secure Medical, Inc.. Device class: 2.

Clearance details

Applicant: Secure Medical, Inc.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1992-12-04
Decision date: 1993-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPE

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K252079 — Disposable Infusion Bag for Parenteral Nutrition2026-04-02
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K251139 — KabiHelp® Uno; KabiHelp® Advance plus2026-01-09
K252094 — eZSURE Empty Fluid Container2025-08-01
K250459 — DMRX 100ml Empty Container Solution +3 more2025-04-18

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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 K926123

K-number listed on FDA's recall record

Z-2262-2016 — Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mLClass II·Terminated·The Metrix Company·20160623

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K926123.

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