510(k) · Cleared
ClearedAri Standard Anesthesia Record
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Dec 19, 1985 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Dec 19, 1985
- Review
- 63 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK854213 Ari Standard Anesthesia RecordAgilent Technologies, Inc. · 1985
- Descendant · cites it directly · 8 of its ownK030939 Philips Compurecord Peri-Operative Information System SoftwarePhilips Medical Systems · 2003
- Descendant · 2 generations on · 6 of its ownK050883 Safersleep SystemSafer Sleep, LLC · 2005
- Descendant · 2 generations on · 5 of its ownK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
- Descendant · 3 generations on · 2 of its ownK141474 Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · Recalled
- Descendant · 4 generations on · 1 of its ownK182092 BD Intelliport SystemBecton, Dickinson and Company · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K030939Philips Compurecord Peri-Operative Information System SoftwarePhilips Medical Systems · 2003 · cites it directly8descendants
- K050883Safersleep SystemSafer Sleep, LLC · 2005 · 2 generations on6descendants
- K062388Anesthesia Information and Digital-Drug Management SystemDocusys · 2007 · 2 generations on5descendants
- K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · 3 generations on2descendants
- K182092BD Intelliport SystemBecton, Dickinson and Company · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854213 | Ari Standard Anesthesia Record | Agilent Technologies, Inc. | 1985 | — |
| +1 | K030939 | Philips Compurecord Peri-Operative Information System Software | Philips Medical Systems | 2003 | — |
| +2 | K050883 | Safersleep System | Safer Sleep, LLC | 2005 | — |
| +2 | K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | 2007 | — |
| +3 | K141474 | Becton Dickinson Intelliport System | Becton, Dickinson & CO | 2014 | 1 |
| +4 | K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BSZ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030939 | Philips Compurecord Peri-Operative Information System Software | 2003 | 8 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030939 (Philips Medical Systems, 2003) has gone furthest, with 8 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.
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) | — |
https://510kreport.com/device/K854213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854213: Ari Standard Anesthesia Record.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854213
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026