510(k) · Cleared
ClearedNarkomed 6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical, Inc. · MLC Monitor, St Segment
Cleared on Mar 23, 2000 as substantially equivalent to K980553 (Draeger Medical, Inc., 1998) and 2 other predicates after a 132-day review. Its family tree reaches back 2 generations to 1990. 4 of the 20 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Mar 23, 2000
- Review
- 132 days
- Class
- Class II
- Product code
- MLC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K901713 (1990). 3 ancestors in all. 16 later devices descend from it, 1 citing it directly. 4 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- 1 generation backK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- This deviceK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- Descendant · cites it directly · 15 of its ownK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 14 of its ownK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- Descendant · 2 generations on · 10 of its ownK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K033498Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · cites it directly15descendants
- K041622Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 2 generations on14descendants
- K042607Primus USDraeger Medical, Inc. · 2004 · 2 generations on10descendants
- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on5descendants
- K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| −1 | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| 0 (this device) | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| +1 | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | 1 |
| +2 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +2 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| +3 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +3 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K980553 | Narkomed 6000 Model Number NM6000Summary page 1…y Road Telford, Pennsylvania 18969 Establishment Registration Number: 2517967 Devices to which substantial equivalence is claimed: Narkomed 6000 Anesthesia Workstation K980553 Marquette SL Series Transport Remote Acquisistion K921669 Narkomed 4 Anesthesia System K901713 Device Description: The NM6000… | 1998 |
| * | K921669 | Marquette SL Series Transport Remote AcquisitionSummary page 1…ion Number: 2517967 Devices to which substantial equivalence is claimed: Narkomed 6000 Anesthesia Workstation K980553 Marquette SL Series Transport Remote Acquisistion K921669 Narkomed 4 Anesthesia System K901713 Device Description: The NM6000 Anesthesia Workstation has been modified to include optiona… | 1993 |
| * | K901713 | Narkomed 4 Anesthesia SystemSummary page 1…substantial equivalence is claimed: Narkomed 6000 Anesthesia Workstation K980553 Marquette SL Series Transport Remote Acquisistion K921669 Narkomed 4 Anesthesia System K901713 Device Description: The NM6000 Anesthesia Workstation has been modified to include optional Cardiovascular and Strip Chart Reco… | 1990 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033498 | Narkomed 6400, Model NM6400 | 2004 | 15 |
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 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K033498 (Draeger Medical, Inc., 2004) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K980553.
How does its category compare?
All MLC devicesMLC Monitor, St Segment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLC
FDA has decided no MLC device since 2007.
Median 510(k) review, days · MLC
Too few MLC 510(k)s in any year since 2007 to give a median.
Recalls per year · MLC
No recall names MLC since 2007.
Adverse event reports per year · MLC
No MAUDE report names MLC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NM6000 w/ CV & SCR in indicated as a continuous flow anesthesia system. The NM6000 w/ CV & SCR 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993826 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993826: Narkomed 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993826
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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