# K160950: Miniscav

- Pathway: 510(k) (Traditional)
- Applicant: Sedation Systems, LLC
- Decided: May 5, 2017 after 395 days
- Product code: CBN (Apparatus, Gas-Scavenging)
- Device class: 2
- Regulation: 21 CFR 868.5430
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K895761 (1989). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110930: Active Waste Gas Scavenger, G. Dundas Co.,Inc. (2011) Summary page 4.
- K150134: Basic, Dominant Flex, KV-6, Medela AG (2015) Summary page 4.

## Recalls of this device
- Aug 23, 2023 · Class II · Z-2619-2023: Inadequate documentation of acceptance activity

## Indications for use
The MINISCAV™ waste gas evacuation apparatus is intended to remove patients’ exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures of nitrous oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases. This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.

Source page: https://510kreport.com/device/K160950
Methodology: https://510kreport.com/methodology