510(k) · Cleared
ClearedDatex as/3 TM Anaesthesia Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex Division Instrumentarium Corp. · BSZ Gas-Machine, Anesthesia
Cleared on Nov 14, 1994 after a 496-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- Nov 14, 1994
- Review
- 496 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- This deviceK933285 Datex as/3 TM Anaesthesia MonitorDatex Division Instrumentarium Corp. · 1994
- Descendant · cites it directly · 11 of its ownK043276 Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and…Datex-Ohmeda · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 7 of its ownK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
- Descendant · 5 generations on · 5 of its ownK151063 Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · cites it directly11descendants
- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 2 generations on10descendants
- K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 3 generations on8descendants
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on7descendants
- K151063Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933285 | Datex as/3 TM Anaesthesia Monitor | Datex Division Instrumentarium Corp. | 1994 | — |
| +1 | K043276 | Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module | Datex-Ohmeda | 2004 | Class I |
| +2 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
| +3 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
| +4 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | Class I |
| +5 | K151063 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 1 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
2 devices in this family have a Class I recall. 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 BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 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? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043276 | Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module Class I | 2004 | 11 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K043276 (Datex-Ohmeda, 2004) has gone furthest, with 11 descendants of its own.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, 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 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
https://510kreport.com/device/K933285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933285: Datex as/3 TM Anaesthesia Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933285
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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