510(k) · Cleared
ClearedFlowStar Touch Digital Mixer Flowmeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baldus Sedation GmbH & Co. KG · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Jul 28, 2023 as substantially equivalent to K052335 (Accutron, Inc., 2005) after a 315-day review. Its family tree reaches back 2 generations to 1994. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 28, 2023
- Review
- 315 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945722 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK945722 Matrx MDM, RAMatrx Medical, Inc. · 1994
- 1 generation backK052335 Analgesia Gas Machine, Model Digital UltraAccutron, Inc. · 2005 · Recalled (Class I)
- This deviceK222794 FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG · 2023
- Descendant · cites it directly · 0 of its ownK241465 Midas Flowmeter; eAVSParker Hannifin Corporation · 2024
Class I recalls in this family
- K052335 Analgesia Gas Machine, Model Digital Ultradirect predicate · 2005
Most influential descendants
Showing 1 of 1 · See all- K241465Midas Flowmeter; eAVSParker Hannifin Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945722 | Matrx MDM, RA | Matrx Medical, Inc. | 1994 | — |
| −1 | K052335 | Analgesia Gas Machine, Model Digital Ultra | Accutron, Inc. | 2005 | Class I |
| 0 (this device) | K222794 | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023 | — |
| +1 | K241465 | Midas Flowmeter; eAVS | Parker Hannifin Corporation | 2024 | — |
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 |
|---|---|---|
| 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 BZR device
- #1 K243917 F&P Optiflow Air/Oxygen Flow Sourcescore 12.1 · 9 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 |
|---|---|---|---|
| * | K052335 | Analgesia Gas Machine, Model Digital UltraSummary page 4…wmeter Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR 2) Equivalent legally marketed device: K052335 Trade/Device Name: Accutron Digital Ultra Manufacturer: Accutron, Inc. Regulation Name: Breathing Gas Mixer Regulator… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241465 | Midas Flowmeter; eAVS | 2024 | 0 |
Has anything in its family been recalled? (1 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.
- K052335Analgesia Gas Machine, Model Digital UltraAccutron, Inc. · 2005 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K241465 (Parker Hannifin Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052335.
How does its category compare?
All BZR devicesBZR Mixer, Breathing Gases, Anesthesia Inhalation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · BZR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZR
203in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZR
No recall names BZR since 2007.
Adverse event reports per year · BZR
13in 2025
MAUDE reports naming product code BZR, 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 | 0 | — | 0 | 15 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 2 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 1 | — | 0 | 39 |
| 2016 | 1 | — | 0 | 30 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 4 | 203 | 0 | 19 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222794 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222794: FlowStar Touch Digital Mixer Flowmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222794
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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