# K063018: Glass Loss of Resistance Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Jan 22, 2007 after 112 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Glass Loss of Resistance Syringe: named in the summary without a submission number

## Indications for use
The Glass Loss of Resistance 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 loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.

Source page: https://510kreport.com/device/K063018
Methodology: https://510kreport.com/methodology
