HORIZON PUMP Y-TYPE BLOOD SET— 510(k) K922637
Substantially EquivalentMcgaw, Inc.
FDA 510(k) clearance K922637 for HORIZON PUMP Y-TYPE BLOOD SET, Substantially Equivalent on 1993-06-04. Applicant: Mcgaw, Inc.. Device class: 2.
Clearance details
- Applicant
- Mcgaw, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- 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 FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 K922637
K-number listed on FDA's recall record- Z-0618-2026 — Blood Administration 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. Y-TYPE BLOOD SET, 3 CARSITE LADS, 146 IN; Catalog Number: 490530.
- Z-0619-2026 — Blood Administration 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. Y-TYPE BLOOD SET, HAND PUMP, 146 IN.; Catalog Number: 490438.
- Z-0620-2026 — Blood Administration 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. Y-TYPE BLOOD SET W/ 170¿M FILTER; Catalog Number: 480233.
- Z-2548-2021 — 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
- Z-2553-2021 — Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
- Z-2559-2021 — Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
- Z-2560-2021 — Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
- Z-0935-2020 — Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
- Z-0937-2020 — Y-Type Blood Set, Catalog Number 490314
- Z-0939-2020 — Y-Type Blood Set, Catalog Number 490530
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K922637.
Data sourced from openFDA. This site is unofficial and independent of the FDA.