CONCENTRATED PLATELET ADMIN. SET— 510(k) K840212
Substantially EquivalentAmerican Mcgaw
FDA 510(k) clearance K840212 for CONCENTRATED PLATELET ADMIN. SET, Substantially Equivalent on 1984-03-06. Applicant: American Mcgaw. Device class: 2.
Clearance details
- Applicant
- American Mcgaw
- 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
- Mchenry, IL, US
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More clearances from American Mcgaw
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 K840212
K-number listed on FDA's recall record- Z-0616-2026 — 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 124 IN.; Catalog Number: 490196.
- Z-0617-2026 — 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 120 IN; Catalog Number: 490355.
- 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-0936-2020 — Y-Type Blood Set, Catalog Number 490293
- Z-0937-2020 — Y-Type Blood Set, Catalog Number 490314
- Z-0938-2020 — Y-Type Blood Set, Catalog Number 490425
- Z-0940-2020 — Safeline Y-Type Blood Set, Catalog Number NF5140
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K840212.
Data sourced from openFDA. This site is unofficial and independent of the FDA.