510(k) · Cleared
ClearedA5 Anesthesia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · BSZ Gas-Machine, Anesthesia
Cleared on Jan 12, 2018 as substantially equivalent to K123211 (Datascope Corp., Patient Monitoring Division, 2013) after a 255-day review. Its family tree reaches back 9 generations to 1994. 2 of the 19 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 12, 2018
- Review
- 255 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930017 (1994). 18 ancestors in all. No later device cites it as a predicate yet. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 5 generations between
- 3 generations backK080175 Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division · 2008 · Recalled
- 2 generations backK102471 AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · Recalled (Class I)
- 1 generation backK123211 A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division · 2013 · Recalled
- This deviceK171311 A5 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
Show all 9 generations
- Root · 9 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 8 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- 7 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
- 6 generations backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
- 5 generations backK061609 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2006 · Recalled
- 4 generations backK071142 GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
- 3 generations backK080175 Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division · 2008 · Recalled
- 2 generations backK102471 AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · Recalled (Class I)
- 1 generation backK123211 A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division · 2013 · Recalled
- This deviceK171311 A5 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| −8 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| −7 | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | Datex-Ohmeda, Inc. | 2004 | — |
| −6 | K042154 | GE Datex-Ohmeda Aisys Carestation | Datex-Ohmeda, Inc. | 2004 | 3 |
| −5 | K061609 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2006 | 1 |
| −4 | K071142 | GE Datex-Ohmeda Avance Anesthesia System | Datex-Ohmeda | 2007 | — |
| −3 | K080175 | Navigator Anesthesia Delivery System, Model 0998-00-3024-01 | Datascope Corp., Patient Monitoring Division | 2008 | 2 |
| −2 | K102471 | AS3700 Anesthsia Delivery System | Mindray DS USA, Inc. | 2011 | Class I |
| −1 | K123211 | A5 Anesthesia Delivery System | Datascope Corp., Patient Monitoring Division | 2013 | 1 |
| 0 (this device) | K171311 | A5 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 |
| 2008 | 2 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K123211 | A5 Anesthesia Delivery SystemSummary page 5…Manufacturer name Shenzhen Mindray Bio- K123211 A5 Anesthesia Delivery System Medical Electronics Co.… | 2013 |
| † | K151954 | A7 Anesthesia System | 2015 |
| † | K083050 | Evite XL | 2008 |
| † | K110213 | GE Datex-Ohmeda Aisys | 2011 |
| † | K132530 | GE Datex-Ohmeda Aisys CS2 (Aisys CS^2) | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 18 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K123211.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 A5 Anesthesia 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 A5 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171311: A5 Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171311
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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