510(k) · Cleared
ClearedEasyflow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epm Information Systems, Inc. · BZQ Monitor, Breathing Frequency
Cleared on Dec 7, 1992 after a 216-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 7, 1992
- Review
- 216 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK922112 EasyflowEpm Information Systems, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK042253 Sleepsense Sleep SensorsS.L.P., Ltd. · 2004
- Descendant · 2 generations on · 1 of its ownK173793 XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019
- Descendant · 3 generations on · 0 of its ownK242424 Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK201495 Maxxi Flow SensorNeurovirtual USA, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK180001 Disposable BreathSensor Adult, Disposable BreathSensor Small Adult /…Embla Systems · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042253Sleepsense Sleep SensorsS.L.P., Ltd. · 2004 · cites it directly4descendants
- K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019 · 2 generations on1descendant
- K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc. · 2024 · 3 generations on0descendants
- K201495Maxxi Flow SensorNeurovirtual USA, Inc. · 2020 · cites it directly0descendants
- K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable…Embla Systems · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922112 | Easyflow | Epm Information Systems, Inc. | 1992 | — |
| +1 | K042253 | Sleepsense Sleep Sensors | S.L.P., Ltd. | 2004 | — |
| +2 | K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | 2019 | — |
| +3 | K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. | 2024 | — |
| +1 | K201495 | Maxxi Flow Sensor | Neurovirtual USA, Inc. | 2020 | — |
| +2 | K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child… | Embla Systems | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZQ? 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 BZQ device
- #1 K251326 Respiration Rate algorithmscore 20.2 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042253 (S.L.P., Ltd., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZQ
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZQ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZQ
2in 2022
MAUDE reports naming product code BZQ, 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 | 2 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 121 | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 3 | 261 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 3 | 198 | 0 | 10 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 2 | — | 0 | 10 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 198 | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 7 | 255 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K922112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K922112: Easyflow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922112
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026