# K031128: B-Smart, Model B-01

- Pathway: 510(k) (Traditional)
- Applicant: Macosta Medical USA, LLC
- Decided: Jan 15, 2004 after 281 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170435: NerveGuard NRFit, NerveGuard LUER (2017), 0 descendants of its own

## Indications for use
The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.

Source page: https://510kreport.com/device/K031128
Methodology: https://510kreport.com/methodology