# K980090: Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)

- Pathway: 510(k) (Traditional)
- Applicant: Luther Medical Products, Inc.
- Decided: Mar 24, 1998 after 74 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930473 (1994). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930473: Onecath L-Cath Catheter System, Luther Medical Products, Inc. (1994). Our OCR of the scanned summary read K930743, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ONECATH”. Summary page 4.

## Most influential descendants
- K992424: Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 & 63246J20 (2000), 4 descendants of its own
- K063363: Firmgrip Peripherally Inserted Catheter Device (2007), 3 descendants of its own
- K080793: Firmgrip (2008), 2 descendants of its own
- K092629: SNM Firmgrip (2009), 1 descendant of its own
- K111939: M/29TM - Pressure Injectable (2012), 0 descendants of its own

## Indications for use
The ONECATH Catheter System is designed for use when patient therapy requires repeated venous access or prolonged intravenous administration of fluids, medications, and/or nutritional solutions as prescribed. The catheter is designed to be inserted in a peripheral vein. While any vessel suitable for insertion may be used; the basilic vein is the most commonly used vein. Note: This product may be used in pediatric as well as adult patients. Vascular cannulation is an important Procedure in the management of ill infants and children. The indications for use in children are the same as adults; however, insertion techniques are often modified according to the age and size of a child. If the practitioner is inexperienced in utilizing this product in a child, appropriate consultation should be sought.

Source page: https://510kreport.com/device/K980090
Methodology: https://510kreport.com/methodology