510(k) · Cleared
ClearedModified Models 2000W and 2000W Option H Apnea Mon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edentec Corp. · BZQ Monitor, Breathing Frequency
Cleared on Jun 20, 1991 after a 190-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jun 20, 1991
- Review
- 190 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK905575 Modified Models 2000W and 2000W Option H Apnea MonEdentec Corp. · 1991
- Descendant · cites it directly · 0 of its ownK962781 Corometrics Model 510 and 511 MonitorGe Medical Systems Information Technologies · 1997 · Recalled
- Descendant · cites it directly · 0 of its ownK963400 Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and N-3200…Nellcor Puritan Bennett, Inc. · 1996
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905575 | Modified Models 2000W and 2000W Option H Apnea Mon | Edentec Corp. | 1991 | — |
| +1 | K962781 | Corometrics Model 510 and 511 Monitor | Ge Medical Systems Information Technologies | 1997 | 1 |
| +1 | K963400 | Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and N-3200… | Nellcor Puritan Bennett, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
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, K962781 (Ge Medical Systems Information Technologies, 1997) has gone furthest, with 0 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/K905575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905575: Modified Models 2000W and 2000W Option H Apnea Mon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905575
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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