510(k) · Cleared
ClearedRFS Vacuum Gauge Scavenging Circuit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accutron, Inc. · CBN Apparatus, Gas-Scavenging
Cleared on Mar 12, 2004 as substantially equivalent to K965239 (Accutron, Inc., 1997) after a 128-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Mar 12, 2004
- Review
- 128 days
- Class
- Class II
- Product code
- CBN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965239 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK965239 Pip Low Profile Scavenging System (260 and 261)/Universal Low…Accutron, Inc. · 1997
- This deviceK033503 RFS Vacuum Gauge Scavenging CircuitAccutron, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK033028 Anefin, Model 100Axon Medical · 2005
- Descendant · 2 generations on · 0 of its ownK092031 Vapor-Clear, Model 100Axon Medical, Inc. · 2010 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965239 | Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile… | Accutron, Inc. | 1997 | — |
| 0 (this device) | K033503 | RFS Vacuum Gauge Scavenging Circuit | Accutron, Inc. | 2004 | — |
| +1 | K033028 | Anefin, Model 100 | Axon Medical | 2005 | — |
| +2 | K092031 | Vapor-Clear, Model 100 | Axon Medical, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 5.2 · 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 |
|---|---|---|---|
| * | K965239 | Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile Scavenging System…Summary page 2…e removal from the treatment location of gases expired by the patient, and removal from tie treatment location any excess gases delivered to a patient. Predicate Devices K965239 PIP Low Profile Scavenging System (Models 260, 260U) Risk Management This device has been designed to either completely eliminate… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033028 | Anefin, Model 100 | 2005 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K033028 (Axon Medical, 2005) has gone furthest, with 1 descendant 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?
To be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases, for the removal from the treatment location of gases expired by the patient, and removal from the treatment location any excess gases delivered to a patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033503: RFS Vacuum Gauge Scavenging Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033503
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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