510(k) · Cleared
Recalled · Class I · 2012Analgesia Gas Machine, Model Digital Ultra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accutron, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Nov 23, 2005 as substantially equivalent to K970163 (Technical Medical Products, Inc., 1997) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Nov 23, 2005
- Review
- 89 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 4 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945722 (1994). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK945722 Matrx MDM, RAMatrx Medical, Inc. · 1994
- This deviceK052335 Analgesia Gas Machine, Model Digital UltraAccutron, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK222794 FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG · 2023
- Descendant · 2 generations on · 0 of its ownK241465 Midas Flowmeter; eAVSParker Hannifin Corporation · 2024
- Descendant · cites it directly · 0 of its ownK062155 Digital MXR-D FlowmeterPorter Instrument Co., Inc. · 2006 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG · 2023 · cites it directly1descendant
- K241465Midas Flowmeter; eAVSParker Hannifin Corporation · 2024 · 2 generations on0descendants
- K062155Digital MXR-D FlowmeterPorter Instrument Co., Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945722 | Matrx MDM, RA | Matrx Medical, Inc. | 1994 | — |
| 0 (this device) | K052335 | Analgesia Gas Machine, Model Digital Ultra | Accutron, Inc. | 2005 | — |
| +1 | K222794 | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023 | — |
| +2 | K241465 | Midas Flowmeter; eAVS | Parker Hannifin Corporation | 2024 | — |
| +1 | K062155 | Digital MXR-D Flowmeter | Porter Instrument Co., Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K970163 | Alpha MX (20)/Ultra PC (30)Summary page 2…de-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%. Predicate Devices K970163 Technical Medical Products Model 20 Alpha MX / Model 30 Ultra PC manufactured by Accutron Inc., Phoenix AZ. K945722 Matrx MDM, RA… | 1997 |
| * | K945722 | Matrx MDM, RASummary page 2…trous oxide concentration of 70%. Predicate Devices K970163 Technical Medical Products Model 20 Alpha MX / Model 30 Ultra PC manufactured by Accutron Inc., Phoenix AZ. K945722 Matrx MDM, RA manufactured by Matrx Medical, Inc., Orchard Park, New York. Voluntary Standards EN 6060 1-1 / IEC 60601-1, "Medic… | 1994 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2012 | Class I | Z-0017-2013 | Device Design | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. |
| Apr 29, 2012 | Class I | Z-0020-2013 | Device Design | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. |
| Apr 29, 2012 | Class I | Z-0018-2013 | Device Design | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. |
| Apr 29, 2012 | Class I | Z-0019-2013 | Device Design | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K222794 (Baldus Sedation GmbH & Co. KG, 2023) has gone furthest, with 1 descendant 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) | — |
What is it indicated for?
To be used in nitrous oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052335: Analgesia Gas Machine, Model Digital Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052335
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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