510(k) · Cleared
ClearedNarkomed 6000 Model Number NM6000
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 Aug 4, 1998 as substantially equivalent to K901713 (Draeger Medical, Inc., 1990) after a 173-day review. Its family tree reaches back 1 generation to 1990. 4 of the 20 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it.
- Decided
- Aug 4, 1998
- Review
- 173 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901713 (1990). 18 later devices descend from it, 2 citing it directly. 4 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- This deviceK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- Descendant · cites it directly · 16 of its ownK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- Descendant · 2 generations on · 15 of its ownK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 14 of its ownK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- Descendant · cites it directly · 11 of its ownK983635 Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc. · 1999
- Descendant · 2 generations on · 10 of its ownK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K993826Narkomed 6000Draeger Medical, Inc. · 2000 · cites it directly16descendants
- K033498Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · 2 generations on15descendants
- K041622Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 3 generations on14descendants
- K983635Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc. · 1999 · cites it directly11descendants
- K042607Primus USDraeger Medical, Inc. · 2004 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| 0 (this device) | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| +1 | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| +2 | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | 1 |
| +3 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +1 | K983635 | Julian Anesthesia Workstation, Model # Julian | Draeger Medical, Inc. | 1999 | — |
| +2 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K901713 | Narkomed 4 Anesthesia SystemSummary page 1…35 Quarry Road Telford, PennsylvaniaA 1§969 Establishment Registration Number: 2517967 Devices to which substantial equivalence is claimed: Narkomed 4 Anesthesia System K901713 Device Description: The NM6000 is a continuous flow gas anesthesia system. Intennded Use: The NM6000 may be used for spontane… | 1990 |
What descends from it? (18)
See all 182 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)
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.
- K133886Perseus A500Draeger Medical GmbH · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 5 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 NM6000 is indicated as a continuous flow anesthesia system. The NM6000 may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. Federal law restricts this device to sale by or on the order of a physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980553: Narkomed 6000 Model Number NM6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980553
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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