# K050753: Stryker Discmonitor

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: May 18, 2005 after 56 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953522 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011811: Monarch Inflation Syringe; Universal Fluid Dispensing Syringe, Merit Medical Systems, Inc. (2001) Summary page 1.
- K973230: Monarch (in 2125)/Intellisystem (in 1125), Merit Medical Systems, Inc. (1997) Summary page 1.
- K993341: Intellisystem II Color Monitor, Merit Medical Systems, Inc. (1999) Summary page 1.
- K033739: Physician Industries' Durameter Syringe, Physician Industries, Inc. (2004) Summary page 1.
- K020333: Atrion Medical QL Fluid Dispensing Syringe, Atrion Medical Products, Inc. (2002) Summary page 1.

## Indications for use
The Stryker Discmonitor is used to inject fluids into the intervertebral disc nucleus during discography procedures and monitor the pressure of that fluid.

Source page: https://510kreport.com/device/K050753
Methodology: https://510kreport.com/methodology