NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,— 510(k) K072080
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K072080 for NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,, Substantially Equivalent on 2008-06-02. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code LGZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
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Adverse events under product code LGZ
product code LGZ- Death
- 16
- Malfunction
- 5,916
- Other
- 1
- Total
- 5,933
Source: openFDA MAUDE database, through . 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 K072080
K-number listed on FDA's recall record- Z-2376-2021 — NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
- Z-2377-2021 — NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072080.
Data sourced from openFDA. This site is unofficial and independent of the FDA.