510(k) · Cleared
ClearedAutomatic Vacuum Switch (Avs) Model Number Avs 5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porter Instrument Co., Inc. · CBN Apparatus, Gas-Scavenging
Cleared on Jun 16, 1998 as substantially equivalent to K761140 (Fraser Sweatman, Inc., 1976) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Jun 16, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- CBN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K761140 (1976). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK761140 Fraser Sweatman's Double MaskFraser Sweatman, Inc. · 1976
- This deviceK981754 Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K761140 | Fraser Sweatman's Double Mask | Fraser Sweatman, Inc. | 1976 | — |
| 0 (this device) | K981754 | Automatic Vacuum Switch (Avs) Model Number Avs 5000 | Porter Instrument Co., Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 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? (2)
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 |
|---|---|---|---|
| * | K761140 | Fraser Sweatman's Double MaskSummary page 1…tomatic Vacuum Switch (AVS) Classification Name: Anesthesiology Non-classified* Accessory to § 868.5430 Gas scavenging apparatus. Class 2 Substantial Equivalence! to: K761140 Double Mask Fraser Sweatman K802067 Clean Air Pollution Reduction System Porter Instrument Co., Inc. Device Description: I… | 1976 |
| * | K802067 | Clean-Air Pollution Reduction SystemSummary page 1…tion Name: Anesthesiology Non-classified* Accessory to § 868.5430 Gas scavenging apparatus. Class 2 Substantial Equivalence! to: K761140 Double Mask Fraser Sweatman K802067 Clean Air Pollution Reduction System Porter Instrument Co., Inc. Device Description: In accordance with section 510(k) for th… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
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 intended use of the AVS accessory is to control the vacuum flow in a gas scavenging apparatus.
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/K981754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981754: Automatic Vacuum Switch (Avs) Model Number Avs 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981754
Report an extraction error
Are you the manufacturer?
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