# K102192: Indiscal Digital Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Feb 23, 2011 after 203 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020333: Atrion Medical QL Fluid Dispensing Syringe, Atrion Medical Products, Inc. (2002) Summary page 1.
- K033739: Physician Industries' Durameter Syringe, Physician Industries, Inc. (2004) Summary page 1.

## Indications for use
The InDiscaTM1 Digital Manometer is indicated to be used for dispensing fluids into the intervertebral disc and monitoring the pressure of those fluids during discography procedures in symptomatic patients with suspected intervertebral disc pathology.

Source page: https://510kreport.com/device/K102192
Methodology: https://510kreport.com/methodology