510(k) · Cleared
Recalled · Class II · 2022Vapor-Clear, Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Medical, Inc. · CBN Apparatus, Gas-Scavenging
Cleared on Apr 16, 2010 as substantially equivalent to K033028 (Axon Medical, 2005) after a 284-day review. Its family tree reaches back 7 generations to 1997. It has been recalled once.
- Decided
- Apr 16, 2010
- Review
- 284 days
- Class
- Class II
- Product code
- CBN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962603 (1997). 13 ancestors in all, the oldest K913516 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK993979 MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000 · Recalled
- 2 generations backK030886 Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · Recalled
- 1 generation backK033028 Anefin, Model 100Axon Medical · 2005
- This deviceK092031 Vapor-Clear, Model 100Axon Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K993979 | MARSPO2, Model 2001 | Novametrix Medical Systems, Inc. | 2000 | 1 |
| −2 | K030886 | Nico with Mars, Model 7300 | Respironics Novametrix, Inc. | 2003 | 8 |
| −1 | K033028 | Anefin, Model 100 | Axon Medical | 2005 | — |
| 0 (this device) | K092031 | Vapor-Clear, Model 100 | Axon Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 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.
Planning a device in CBN? 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 CBN device
- #1 K223452 Nitronox Scavenger Plusscore 5.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K033028 | Anefin, Model 100Summary page 2…April 7, 2010 Summary of comparison between device and predicate~s)__________ Attribute Vapor 7Clear (K092031) AneFin (K033028) Comparison General indications for Remove unwanted Remove unwanted Identical use… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2022 | Class II | Z-1591-2023 | Employee error | Due to a manufacturing issue that may result in filter leakage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 5 of the 13 ancestors have a recall of any class.
How does its category compare?
All CBN devicesCBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CBN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CBN
Too few CBN 510(k)s in any year since 2007 to give a median.
Recalls per year · CBN
No recall names CBN since 2007.
Adverse event reports per year · CBN
1in 2025
MAUDE reports naming product code CBN, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To remove unwanted anesthetic gases from the patient breathing circuit
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092031: Vapor-Clear, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092031
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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