VOLUMETRIC INFUSION PUMP— 510(k) K904518
Substantially EquivalentKendall Mcgaw Laboratories, Inc.
FDA 510(k) clearance K904518 for VOLUMETRIC INFUSION PUMP, Substantially Equivalent on 1990-10-17. Applicant: Kendall Mcgaw Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kendall Mcgaw Laboratories, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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More clearances from Kendall Mcgaw Laboratories, Inc.
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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 K904518
K-number listed on FDA's recall record- Z-2552-2021 — OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
- Z-2166-2013 — Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904518.
Data sourced from openFDA. This site is unofficial and independent of the FDA.