510(k) · Cleared
Recalled · Class II · 2018Equinox Relieve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O-Two Medical Technologies, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Apr 30, 2012 as substantially equivalent to K883833 (Matrix Medica, Inc., 1989) and 1 other predicate after a 137-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 30, 2012
- Review
- 137 days
- Class
- Class II
- Product code
- BZR
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932170 (1993). 6 ancestors in all, the oldest K883833 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK932170 Flynnr Genesis II a/C, a/O and IdlhO-Two Systems Intl., Inc. · 1993
- 2 generations backK983643 Genesis BLSO-Two Systems Intl., Inc. · 1998
- 1 generation backK991195 Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and…O-Two Systems Intl., Inc. · 1999
- This deviceK113687 Equinox RelieveO-Two Medical Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK173205 Equinox AdvantageO-Two Medical Technologies, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173205Equinox AdvantageO-Two Medical Technologies, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932170 | Flynnr Genesis II a/C, a/O and Idlh | O-Two Systems Intl., Inc. | 1993 | — |
| −2 | K983643 | Genesis BLS | O-Two Systems Intl., Inc. | 1998 | — |
| −1 | K991195 | Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent Atv | O-Two Systems Intl., Inc. | 1999 | — |
| 0 (this device) | K113687 | Equinox Relieve | O-Two Medical Technologies, Inc. | 2012 | — |
| +1 | K173205 | Equinox Advantage | O-Two Medical Technologies, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZR device
- #1 K243917 F&P Optiflow Air/Oxygen Flow Sourcescore 12.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883833 | Nitronox (R), First Response Nitronox (TM)Summary page 1…ogy Predicate Devices: Nitronox® * Manufactured by Matrix Medica Inc. * 510(k) number K883833 CAREvent AJ*LS+ * Manufactured by 0-Two Medical Technologies… | 1989 |
| * | K991195 | Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent AtvSummary page 1…CAREvent AJ*LS+ * Manufactured by 0-Two Medical Technologies Inc. * 510(k) number K991 195 Device Description: The proposed Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173205 | Equinox Advantage | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2018 | Class II | Z-2887-2018 | Under Investigation by firm | 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 | Device Design | Higher levels of nitrous oxide delivered than specification |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K173205 (O-Two Medical Technologies, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K883833.
How does its category compare?
All BZR devicesBZR Mixer, Breathing Gases, Anesthesia Inhalation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · BZR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZR
203in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZR
No recall names BZR since 2007.
Adverse event reports per year · BZR
13in 2025
MAUDE reports naming product code BZR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 15 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 2 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 1 | — | 0 | 39 |
| 2016 | 1 | — | 0 | 30 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 4 | 203 | 0 | 19 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113687: Equinox Relieve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113687
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026