510(k) · Cleared
ClearedMidas Flowmeter; eAVS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parker Hannifin Corporation · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Sep 19, 2024 as substantially equivalent to K222794 (Baldus Sedation GmbH & Co. KG, 2023) after a 119-day review. Its family tree reaches back 3 generations to 1994. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 19, 2024
- Review
- 119 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945722 (1994). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK945722 Matrx MDM, RAMatrx Medical, Inc. · 1994
- 2 generations backK052335 Analgesia Gas Machine, Model Digital UltraAccutron, Inc. · 2005 · Recalled (Class I)
- 1 generation backK222794 FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG · 2023
- This deviceK241465 Midas Flowmeter; eAVSParker Hannifin Corporation · 2024
Class I recalls in this family
- K052335 Analgesia Gas Machine, Model Digital Ultra2 generations back · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945722 | Matrx MDM, RA | Matrx Medical, Inc. | 1994 | — |
| −2 | K052335 | Analgesia Gas Machine, Model Digital Ultra | Accutron, Inc. | 2005 | Class I |
| −1 | K222794 | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023 | — |
| 0 (this device) | K241465 | Midas Flowmeter; eAVS | Parker Hannifin Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K222794 | FlowStar Touch Digital Mixer FlowmeterSummary page 5…6020 EAVS-5000 6120 4. Primary Predicate Device FlowStar Touch Digital Mixer Flowmeter, K222794 This predicate device has not been subject to a design-related recall. 5. Reference Device Nitronox Scaveng… | 2023 |
| † | K223452 | Nitronox Scavenger Plus | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
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. 2024, 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?
The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241465: Midas Flowmeter; eAVS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241465
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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