510(k) · Cleared
ClearedJulian Anesthesia Workstation, Model # Julian
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 Jan 11, 1999 as substantially equivalent to K980553 (Draeger Medical, Inc., 1998) and 3 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1991. 2 of the 23 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Jan 11, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K902859 (1991). 11 ancestors in all, the oldest K901713 (1990). 11 later devices descend from it, 2 citing it directly. 2 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK961687 EVITA 4Drager, Inc. · 1996
- 1 generation backK970165 Evita 2 DuraDrager, Inc. · 1997
- This deviceK983635 Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc. · 1999
- 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
- Descendant · cites it directly · 2 of its ownK133886 Perseus A500Draeger Medical GmbH · 2014 · Recalled (Class I)
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- 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
- K133886Perseus A500Draeger Medical GmbH · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −1 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| 0 (this device) | K983635 | Julian Anesthesia Workstation, Model # Julian | Draeger Medical, Inc. | 1999 | — |
| +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 | — |
| +1 | K133886 | Perseus A500 | Draeger Medical GmbH | 2014 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (4)
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…Moislinger Allee Libeck, Germany 23558 Establishment Registration Number: 9611500 Devices to which substantial equivalence is claimed: Narkomed 6000 Anesthesia System K980553 Divan K980280 Evita 2 Dura K970165 Combination Oximeter/Carbon Dioxide Gas Analyzer K964239 Device Description: The Julian is… | 1998 |
| * | K980208 | Divan Anesthesia Ventilator Our OCR of the scanned summary read K980280, FDA’s number for Powdered Nitrile Examination Gloves (Blue Colour) (Besglove Medicare Sdn. Bhd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Divan”. | 1998 |
| * | K970165 | Evita 2 DuraSummary page 1…3558 Establishment Registration Number: 9611500 Devices to which substantial equivalence is claimed: Narkomed 6000 Anesthesia System K980553 Divan K980280 Evita 2 Dura K970165 Combination Oximeter/Carbon Dioxide Gas Analyzer K964239 Device Description: The Julian is a continuous flow gas anesthesia sy… | 1997 |
| * | K964239 | Combination Oximeter/Carbon Dioxide Gas AnalyzerSummary page 1…o which substantial equivalence is claimed: Narkomed 6000 Anesthesia System K980553 Divan K980280 Evita 2 Dura K970165 Combination Oximeter/Carbon Dioxide Gas Analyzer K964239 Device Description: The Julian is a continuous flow gas anesthesia system. Intended Use: The Julian may be used for spontaneo… | 1997 |
What descends from it? (11)
See all 112 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)
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.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K042607 (Draeger Medical, Inc., 2004) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K980553.
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 Julian is indicated as a continuous flow anesthesia system. The Julian 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/K983635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983635: Julian Anesthesia Workstation, Model # Julian.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983635
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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