# K960764: Safe-Cath

- Pathway: 510(k) (Traditional)
- Applicant: Scientific Device Manufacturer, LLC
- Decided: Apr 24, 1997 after 423 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 1 cites it directly.
1 of 36 devices in its family (counting itself) has 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) Central Venous Multi-Lumen Catheter with flexible tip (Arrow International): named in the summary without a submission number
- (no number) Temporary Dual and Triple Lumen Catheters (Vas-Cath Incorporated): named in the summary without a submission number

## Most influential descendants
- K984189: Argon Multi-Lumen Central Venous Catheter (1999), 34 descendants of its own
- K032274: Cook Five Lumen Central Venous Catheter (2004), 33 descendants of its own
- K060174: Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm (2006), 32 descendants of its own
- K081113: Cook and Cook Spectrum Central Venous Catheters (2008), 31 descendants of its own
- K101326: NMI IC (2010), 26 descendants of its own

## Indications for use
These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.

Source page: https://510kreport.com/device/K960764
Methodology: https://510kreport.com/methodology