510(k) · Cleared
Recalled · 2010Navigator Anesthesia Delivery System, Model 0998-00-3024-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp., Patient Monitoring Division · BSZ Gas-Machine, Anesthesia
Cleared on Jun 9, 2008 as substantially equivalent to K001988 (Heyer America, Inc., 2001) and 1 other predicate after a 137-day review. Its family tree reaches back 6 generations to 1994. 2 of the 24 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 9, 2008
- Review
- 137 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930017 (1994). 12 ancestors in all. 11 later devices descend from it, 2 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 5 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- 4 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
- 3 generations backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
- 2 generations backK061609 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2006 · Recalled
- 1 generation backK071142 GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
- This deviceK080175 Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division · 2008
- Descendant · cites it directly · 9 of its ownK102471 AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK123211 A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division · 2013 · Recalled
- Descendant · 3 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 4 generations on · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 5 generations on · 3 of its ownK171292 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
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- K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · cites it directly9descendants
- K123211A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division · 2013 · 2 generations on8descendants
- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on5descendants
- K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on4descendants
- K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| −5 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| −4 | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | Datex-Ohmeda, Inc. | 2004 | — |
| −3 | K042154 | GE Datex-Ohmeda Aisys Carestation | Datex-Ohmeda, Inc. | 2004 | 3 |
| −2 | K061609 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2006 | 1 |
| −1 | K071142 | GE Datex-Ohmeda Avance Anesthesia System | Datex-Ohmeda | 2007 | — |
| 0 (this device) | K080175 | Navigator Anesthesia Delivery System, Model 0998-00-3024-01 | Datascope Corp., Patient Monitoring Division | 2008 | — |
| +1 | K102471 | AS3700 Anesthsia Delivery System | Mindray DS USA, Inc. | 2011 | Class I |
| +2 | K123211 | A5 Anesthesia Delivery System | Datascope Corp., Patient Monitoring Division | 2013 | 1 |
| +3 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +4 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
| +5 | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K001988 | Modular | 2001 |
| * | K071142 | GE Datex-Ohmeda Avance Anesthesia SystemSummary page 1…Modular Anesthesia System, Heyer America Inc. (KOO 1988) and Avance Anesthesia System, GE Datex-Ohmeda (K071142). Device description: The Navigator Anesthesia Delivery System is a continuous flow… | 2007 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2010 | Not classified | Z-1313-2010 | Other | An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip. |
| Oct 7, 2008 | Not classified | Z-0319-2009 | Component design/selection | Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack… |
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 4 companies; a new generation was cleared every 1.0 years on median.
- 7 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K102471 (Mindray DS USA, Inc., 2011) has gone furthest, with 9 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. 2008, this device’s year, is highlighted.
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 Navigator Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The Navigator is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080175 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080175: Navigator Anesthesia Delivery System, Model 0998-00-3024-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080175
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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