# K100319: Merit Manifold with Integrated Transducer, Model 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Apr 28, 2010 after 83 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- 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 K913161 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913161: Merit Manifold, Merit Medical Systems, Inc. (1991) Summary page 1.
- K920977: Meritrans (TM) Disposable Transducer, Merit Medical Systems, Inc. (1992) Summary page 1.
- K951722: Perceptor Compensator Morse Manifold, Namic (1996) Summary page 1.

## Indications for use
The Merit Manifold with Integrated Transducer is used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. The device is also used for measurement of blood pressure.

Source page: https://510kreport.com/device/K100319
Methodology: https://510kreport.com/methodology