510(k) · Cleared
Recalled · 2008Digital MXR-D Flowmeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porter Instrument Co., Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Nov 9, 2006 as substantially equivalent to K923781 (Porter Instrument Co., Inc., 1993) and 2 other predicates after a 104-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. It has been recalled once.
- Decided
- Nov 9, 2006
- Review
- 104 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945722 (1994). 4 ancestors in all, the oldest K923781 (1993). 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 · 2 generations backK945722 Matrx MDM, RAMatrx Medical, Inc. · 1994
- 1 generation backK052335 Analgesia Gas Machine, Model Digital UltraAccutron, Inc. · 2005 · Recalled (Class I)
- This deviceK062155 Digital MXR-D FlowmeterPorter Instrument Co., Inc. · 2006
Class I recalls in this family
- K052335 Analgesia Gas Machine, Model Digital Ultradirect predicate · 2005
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) | K062155 | Digital MXR-D Flowmeter | Porter Instrument Co., Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K923781 | MXR-2000 FlowmeterSummary page 1…amne: Elowrneter Classification Namne: Analgesia gas machine 3. PREDICATE DEVICES *Por-ter-instrument Co. MXR2000OFlowmeter (K923781) *Digital Ultra Analgesia Gas Machine (K052335) *Matrx Digital MDM T M, RA (K945722) 4. DE… | 1993 |
| * | K052335 | Analgesia Gas Machine, Model Digital UltraSummary page 1…nalgesia gas machine 3. PREDICATE DEVICES *Por-ter-instrument Co. MXR2000OFlowmeter (K923781) *Digital Ultra Analgesia Gas Machine (K052335) *Matrx Digital MDM T M, RA (K945722) 4. DEVICE DESCRIPTION The proposed Digital MXR-D Flowrne… | 2005 |
| * | K945722 | Matrx MDM, RASummary page 1…*Por-ter-instrument Co. MXR2000OFlowmeter (K923781) *Digital Ultra Analgesia Gas Machine (K052335) *Matrx Digital MDM T M, RA (K945722) 4. DEVICE DESCRIPTION The proposed Digital MXR-D Flowrneter is a modification of the MXR 2000 Flow… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2008 | Not classified | Z-0228-2009 | Employee error | inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas |
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 12 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
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?
The Digital MXR-D Flowmeter is intended for use in nitrous oxide/oxygen sedation systems for the delivery of a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062155: Digital MXR-D Flowmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062155
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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