# K993120: Modified Blood Recipient Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 17, 1999 after 58 days
- Product code: BRZ (Set, Blood Transfusion)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Blood /Solution Sets: named in the summary without a submission number

## Most influential descendants
- K021293: Arteria Blood Filter (2002), 6 descendants of its own
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), 2 descendants of its own
- K210335: Blood Administration Set (2021), 1 descendant of its own
- K153485: ENROUTE Transcarotid Neuroprotection System (2016), 1 descendant of its own

## Recalls of this device
- Apr 28, 2004 · Not classified · Z-0193-05: Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.
- Jul 16, 2003 · Not classified · Z-1160-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1161-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1176-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1172-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1177-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1175-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1178-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1162-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1171-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

## Indications for use
The modified Baxter blood sets have the same intended use as currently marketed Baxter blood sets. The intended use of these sets is the administration of blood, blood components or solutions from a container into the patient’s vascular system through a vascular access device.

Source page: https://510kreport.com/device/K993120
Methodology: https://510kreport.com/methodology