# K033739: Physician Industries' Durameter Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Physician Industries, Inc.
- Decided: Jul 12, 2004 after 227 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: 1 generation back to K904954 (1991). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K913994: Monarch (TM) Inflation Syringe, Merit Medical Systems, Inc. (1992) Summary page 1.
- K904954: Condor Digital Inflation Syringe, Professional Medical Services (1991) Summary page 1.
- K960082: Discography Kit, Spinal Specialties, Inc. (1996) Summary page 1.
- K910503: Discography Kit, B. Braun of America, Inc. (1991) Summary page 1.

## Most influential descendants
- K102192: Indiscal Digital Manometer (2011), 0 descendants of its own
- K050753: Stryker Discmonitor (2005), 0 descendants of its own

## Indications for use
For use in diagnosis of herniated or otherwise diseased intervertebral disks in the human spine. This device has not been evaluated for use in vertebroplasty.

Source page: https://510kreport.com/device/K033739
Methodology: https://510kreport.com/methodology