510(k) · Cleared
Recalled · 2004Narkomed 6400, Model NM6400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Apr 26, 2004 as substantially equivalent to K993826 (Draeger Medical, Inc., 2000) and 2 other predicates after a 173-day review. Its family tree reaches back 3 generations to 1990. 4 of the 22 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled once.
- Decided
- Apr 26, 2004
- Review
- 173 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K901713 (1990). 6 ancestors in all, the oldest K900598 (1990). 15 later devices descend from it, 2 citing it directly. 4 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- 2 generations backK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- 1 generation backK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- This deviceK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK171292 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K041622Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · cites it directly14descendants
- K042607Primus USDraeger Medical, Inc. · 2004 · cites it directly10descendants
- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on5descendants
- K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on4descendants
- K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| −2 | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| −1 | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| 0 (this device) | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | — |
| +1 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +1 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| +2 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
| +3 | K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 1 |
| 2008 | 1 | 1 |
| 2014 | 2 | 1 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 1 |
| 2026 | 2 | 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.
4 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? (3)
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 |
|---|---|---|---|
| * | K993826 | Narkomed 6000Summary page 1…ania 18969 Establishment Registration Number:2517967 Devices to which substantial equivalence is claimed: Narkomed 6000 w/ Cardiovascular and Strip Chart Recorder Pods K993826 Marquette SL Series Transport Remote Acquisition (TRAM) K921669 Solar 7000/8000 System K993757 Device Description: The Narkome… | 2000 |
| * | K921669 | Marquette SL Series Transport Remote AcquisitionSummary page 1…o which substantial equivalence is claimed: Narkomed 6000 w/ Cardiovascular and Strip Chart Recorder Pods K993826 Marquette SL Series Transport Remote Acquisition (TRAM) K921669 Solar 7000/8000 System K993757 Device Description: The Narkomed 6400 w/ Integrated Patient Monitoring is a continuous flow gas… | 1993 |
| * | K993757 | SOLAR 7/8000Summary page 1…is claimed: Narkomed 6000 w/ Cardiovascular and Strip Chart Recorder Pods K993826 Marquette SL Series Transport Remote Acquisition (TRAM) K921669 Solar 7000/8000 System K993757 Device Description: The Narkomed 6400 w/ Integrated Patient Monitoring is a continuous flow gas anesthesia system with cardiov… | 2000 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 15, 2004 | Not classified | Z-0192-05 | Other | rotating knob of the rotary style APL valve can become separated from the assembly. |
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.
- K133886Perseus A500Draeger Medical GmbH · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K041622 (Draeger Medical, Inc., 2004) has gone furthest, with 14 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) | — |
What is it indicated for?
The NM6400 w/IPM is indicated as a continuous flow anesthesia system. The NM6400 w/IPM may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of, oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters, anesthetic agent identification and concentration and provides printed data. Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033498 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033498: Narkomed 6400, Model NM6400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033498
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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