510(k) · Cleared
Recalled · Class II · 2023Miniscav
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedation Systems, LLC · CBN Apparatus, Gas-Scavenging
Cleared on May 5, 2017 as substantially equivalent to K110930 (G. Dundas Co.,Inc., 2011) and 1 other predicate after a 395-day review. Its family tree reaches back 7 generations to 1989. It has been recalled once.
- Decided
- May 5, 2017
- Review
- 395 days
- Class
- Class II
- Product code
- CBN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K895761 (1989). 21 ancestors in all, the oldest K832274 (1983). No later device cites it as a predicate yet.
- Root · 7 generations backK895761 General AsperatorKolster Methods · 1989
- 6 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
- 5 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
- 4 generations backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
- 3 generations backK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
- 2 generations backK063336 Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007
- 1 generation backK150134 Basic, Dominant Flex, KV-6Medela AG · 2015
- This deviceK160950 MiniscavSedation Systems, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −6 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| −5 | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| −4 | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-Iii | Hk Surgical, Inc. | 2003 | — |
| −3 | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model… | Moeller Medical GmbH & Co. KG | 2006 | — |
| −2 | K063336 | Medela Dominant 50 Lipo, Model 600-5706 | Medela AG | 2007 | — |
| −1 | K150134 | Basic, Dominant Flex, KV-6 | Medela AG | 2015 | — |
| 0 (this device) | K160950 | Miniscav | Sedation Systems, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K110930 | Active Waste Gas ScavengerSummary page 4…Apparatus, Gas Scavenging Product Classification CBN, 21CFR 868.5430, Class II Predicate Devices: G. Dundas, Active Waste Gas Scavenger System, K110930 Medela, Dominant Flex Suction Pumps, K150134 Device Description: The MINISCAV™ is a small, portable, vacuum pump… | 2011 |
| * | K150134 | Basic, Dominant Flex, KV-6Summary page 4…CBN, 21CFR 868.5430, Class II Predicate Devices: G. Dundas, Active Waste Gas Scavenger System, K110930 Medela, Dominant Flex Suction Pumps, K150134 Device Description: The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a… | 2015 |
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 |
|---|---|---|---|---|
| Aug 23, 2023 | Class II | Z-2619-2023 | Process control | Inadequate documentation of acceptance activity |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 21 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. 2017, 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?
The MINISCAV™ waste gas evacuation apparatus is intended to remove patients’ exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures of nitrous oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.
This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
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/K160950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160950: Miniscav.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160950
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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