510(k) · Cleared
ClearedAnefin, Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Medical · CBN Apparatus, Gas-Scavenging
Cleared on Jul 22, 2005 as substantially equivalent to K033503 (Accutron, Inc., 2004) and 1 other predicate after a 665-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Jul 22, 2005
- Review
- 665 days
- Class
- Class II
- Product code
- CBN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K962603 (1997). 12 ancestors in all, the oldest K913516 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK993979 MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000 · Recalled
- 1 generation backK030886 Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · Recalled
- This deviceK033028 Anefin, Model 100Axon Medical · 2005
- Descendant · cites it directly · 0 of its ownK092031 Vapor-Clear, Model 100Axon Medical, Inc. · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K092031Vapor-Clear, Model 100Axon Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K993979 | MARSPO2, Model 2001 | Novametrix Medical Systems, Inc. | 2000 | 1 |
| −1 | K030886 | Nico with Mars, Model 7300 | Respironics Novametrix, Inc. | 2003 | 8 |
| 0 (this device) | K033028 | Anefin, Model 100 | Axon Medical | 2005 | — |
| +1 | K092031 | Vapor-Clear, Model 100 | Axon Medical, Inc. | 2010 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 5.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K033503 | RFS Vacuum Gauge Scavenging Circuit Cleared while this submission was under review Summary page 1…77-0363 Joseph Orr - President AneFin 100 Rebreathing / Absorber Gas Scavenging Apparatus CBN Rebreathing Device BYW RFS Vacuum gauge scavenging circuit, Accutron - K033503 “protect-OR™ filter, Charcoal based scavenging device, Foregger - Pre-Amendment Model A160 CO, absorber with bypass valve Penlo… | 2004 |
| * | K030886 | Nico with Mars, Model 7300 Cleared while this submission was under review Summary page 1…ce, Foregger - Pre-Amendment Model A160 CO, absorber with bypass valve Penlon, 510(k) exempt Non invasive cardiac output monitor, NICO (Product code: CCK) Novametrix - K030886 Device Description: The AncFin combines an anesthetic gas absorber to remove anesthetic gas from inhaled air and a rebreathing h… | 2003 |
| * | — | protect-OR™ filter, Charcoal based scavenging device Named without a submission number | |
| * | — | Model A160 CO₂ absorber with bypass valve Named without a submission number |
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 |
|---|---|---|---|
| K092031 | Vapor-Clear, Model 100 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K092031 (Axon Medical, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CBN devicesCBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The AneFin 100 is intended to speed emergence from the effects of volatile inhaled anesthetics by removing unwanted anesthetic gases and increasing spontancous breathing through partial rebreathing.
it is intended for use with only Isoflurane, Sevoflurane and Desflurane.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033028: Anefin, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033028
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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