# K113687: Equinox Relieve

- Pathway: 510(k) (Traditional)
- Applicant: O-Two Medical Technologies, Inc.
- Decided: Apr 30, 2012 after 137 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932170 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883833: Nitronox (R), First Response Nitronox (TM), Matrix Medica, Inc. (1989) Summary page 1.
- K991195: Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent Atv, O-Two Systems Intl., Inc. (1999) Summary page 1.

## Most influential descendants
- K173205: Equinox Advantage (2018), 0 descendants of its own

## Recalls of this device
- May 15, 2018 · Class II · Z-2887-2018: Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
- May 14, 2018 · Class II · Z-2885-2018: Higher levels of nitrous oxide delivered than specification

## Indications for use
The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for delivering a 50%/50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.

Source page: https://510kreport.com/device/K113687
Methodology: https://510kreport.com/methodology