# K830755: I.V. Sets Walrus Brand Various Configur-

- Pathway: 510(k) (Traditional)
- Applicant: Medical Parameters, Inc.
- Decided: Apr 28, 1983 after 49 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 7, 2018 · Class II · Z-0097-2019: Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter
- Feb 1, 2010 · Not classified · Z-1128-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1115-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1119-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1121-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1120-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1112-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1130-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1124-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1116-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1123-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1125-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1113-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1126-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1129-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1127-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1117-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1114-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1118-2010: Sterility may be compromised.
- Feb 1, 2010 · Not classified · Z-1122-2010: Sterility may be compromised.
- Feb 11, 2009 · Not classified · Z-1489-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
- Feb 11, 2009 · Not classified · Z-1490-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

Source page: https://510kreport.com/device/K830755
Methodology: https://510kreport.com/methodology