MODIFIED VOLUMETRIC INFUSION PUMP— 510(k) K913661
Substantially EquivalentMcgaw, Inc.
FDA 510(k) clearance K913661 for MODIFIED VOLUMETRIC INFUSION PUMP, Substantially Equivalent on 1991-12-18. Applicant: Mcgaw, Inc.. Device class: 2.
Clearance details
- Applicant
- Mcgaw, 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 Mcgaw, 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 K913661
K-number listed on FDA's recall record- Z-0706-2026 — Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET,3 CARESITE LADS,115 IN.; Catalog Number: 490361.
- Z-0707-2026 — Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/3 CARESITE; Catalog Number: 354213.
- Z-0709-2026 — Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/2 CARESITE; Catalog Number: 354212.
- Z-0716-2026 — Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DR W/2 CARESITE FILTER; Catalog Number: 354214.
- Z-2376-2024 — OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
- Z-2377-2024 — OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
- Z-2404-2024 — OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
- Z-2544-2021 — 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
- Z-2545-2021 — Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
- Z-2546-2021 — Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
- Z-2547-2021 — 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
- Z-2549-2021 — Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
- Z-2550-2021 — ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
- Z-2551-2021 — V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
- Z-2554-2021 — OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
- Z-2555-2021 — PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
- Z-2556-2021 — OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
- Z-2557-2021 — OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
- Z-2558-2021 — Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K913661.
Data sourced from openFDA. This site is unofficial and independent of the FDA.