510(k) · Cleared
Recalled · 2009Primus US
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 Nov 26, 2004 as substantially equivalent to K041622 (Draeger Medical, Inc., 2004) and 4 other predicates after a 63-day review. Its family tree reaches back 5 generations to 1990. 2 of the 39 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 26, 2004
- Review
- 63 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 5 generations to K901713 (1990). 28 ancestors in all, the oldest K900598 (1990). 10 later devices descend from it, 4 citing it directly. 2 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- 4 generations backK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- 3 generations backK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- 2 generations backK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · Recalled
- 1 generation backK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- This deviceK042607 Primus USDraeger Medical, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · cites it directly · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK171292 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK133886 Perseus A500Draeger Medical GmbH · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK230931 AtlanDrägerwerk AG Co. Kgaa · 2023 · Recalled (Class I)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly5descendants
- K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly4descendants
- K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018 · 2 generations on3descendants
- K133886Perseus A500Draeger Medical GmbH · 2014 · cites it directly2descendants
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| −4 | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| −3 | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| −2 | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | 1 |
| −1 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| 0 (this device) | K042607 | Primus US | Draeger Medical, Inc. | 2004 | — |
| +1 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +1 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
| +2 | K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| +1 | K133886 | Perseus A500 | Draeger Medical GmbH | 2014 | Class I |
| +2 | K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (5)
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 |
|---|---|---|---|
| * | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemSummary page 1…any Establishment Registration Number: 9611500 Devices to which substantial equivalence is claimed: Fabius GS Anesthesia Workstation (Fabius GS) K041622 Julian Anesthesia Work-station (Julian) K983635 Nark-omed 6400 w/IPM Anesthesia Workstation (NM6400)… | 2004 |
| * | K983635 | Julian Anesthesia Workstation, Model # JulianSummary page 1…l equivalence is claimed: Fabius GS Anesthesia Workstation (Fabius GS) K041622 Julian Anesthesia Work-station (Julian) K983635 Nark-omed 6400 w/IPM Anesthesia Workstation (NM6400) K033498 Divan Ventilator… | 1999 |
| * | K033498 | Narkomed 6400, Model NM6400Summary page 1…K041622 Julian Anesthesia Work-station (Julian) K983635 Nark-omed 6400 w/IPM Anesthesia Workstation (NM6400) K033498 Divan Ventilator K(980208 Varros w/ Return Sample Gas (Varnos wI RGS)… | 2004 |
| * | K980208 | Divan Anesthesia VentilatorSummary page 1…K983635 Nark-omed 6400 w/IPM Anesthesia Workstation (NM6400) K033498 Divan Ventilator K(980208 Varros w/ Return Sample Gas (Varnos wI RGS) K040847 Device Description: The Primus US, is a continuou… | 1998 |
| * | K040847 | Modification to Vamos Anesthetic Gas MonitorSummary page 1…K033498 Divan Ventilator K(980208 Varros w/ Return Sample Gas (Varnos wI RGS) K040847 Device Description: The Primus US, is a continuous flow gas anesthesia system that delivers anesthetic vapor, provides for aut… | 2004 |
| † | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio | 2003 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2009 | Not classified | Z-1955-2009 | Equipment maintenance | Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete. |
| Aug 22, 2008 | Not classified | Z-0087-2009 | Nonconforming Material/Component | Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed. |
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.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K142552 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2015) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K041622.
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 Primus US is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen and C02 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. 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/K042607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042607: Primus US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042607
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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