# K261372: Profoject™ LOR Syringe

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Sep 25, 2026 after 151 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925902 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061737: Loss of Resistance Syringe, Robert Busse & Co., Inc. (2006) Summary page 6.

## Indications for use
Profoject™ LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique, it will be filled with air and/or saline during use. The LOR Syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged, and as part of a sterile kit. The intended patient population includes children, adolescents, and adults.

Source page: https://510kreport.com/device/K261372
Methodology: https://510kreport.com/methodology