# K030209: Mahurkar Oplus Catheter, Model 13.5 FR

- Pathway: 510(k) (Traditional)
- Applicant: The Kendall Company
- Decided: May 13, 2003 after 112 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
1 of 6 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) MAHURKARB Triple Lumen Catheter: named in the summary without a submission number
- (no number) MAHURKARB Dual Lumen Catheter: named in the summary without a submission number

## Most influential descendants
- K120674: Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter (2012), 1 descendant of its own
- K063355: D-Line Catheter ST, Double Lumen ST; Extra Flow (2007), 1 descendant of its own
- K200426: Acute Dual Lumen Hemodialysis Catheter (2020), 0 descendants of its own
- K192302: Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter (2020), 0 descendants of its own
- K102833: Disposable Hemodialysis Access Catheter Sets (2011), 0 descendants of its own

## Recalls of this device
- Dec 7, 2022 · Class I · Z-0877-2023: There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Apr 29, 2019 · Class II · Z-1955-2019: The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
- Dec 2, 2003 · Not classified · Z-0233-04: Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm
- Dec 2, 2003 · Not classified · Z-0234-04: Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm

## Indications for use
MAHURKARm QPLUSB Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

Source page: https://510kreport.com/device/K030209
Methodology: https://510kreport.com/methodology