# K994306: Reverso

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Mar 20, 2000 after 90 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K953823 (1996). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953823: Arterial Venous Blood Tubing Set, Medisystems Corp. (1996) Summary page 1.

## Most influential descendants
- K022536: \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector (2002), 7 descendants of its own
- K172238: CAREline Airless Hemodialysis Blood Tubing Sets (2017), 6 descendants of its own
- K201207: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (2020), 5 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own

## Indications for use
Medisystems Blood Tubing Set Accessories are indicated for use as a part of an extracorporeal blood circuit for hemodialysis. The specific indications for use each accessory are as follows: a. The Reverso™ is indicated for use as an access flow reversing valve to reverse the blood flow to and from the arterial and venous access devices during hemodialysis procedures without the need to clamp and disconnect bloodlines. b. The Recirculation Connector is indicated for use as a male to male Luer adaptor. c. The Parallel Dialyzer Connector is indicated for use to interconnect two hemodialyzers in parallel as prescribed by the physician as part of the extracorporeal blood system. d. The Series Dialyzer Connector is indicated for use to interconnect two hemodialyzers in series as prescribed by the physician as part of the extracorporeal blood system.

Source page: https://510kreport.com/device/K994306
Methodology: https://510kreport.com/methodology