510(k) · Decided
DecidedBAROnova Insufflation System, BAROnova Accessory Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baronova, Inc. · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on May 14, 2019 as substantially equivalent to K111648 (Bracco Diagnostic, Inc., 2011) after a 29-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- May 14, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K923982 (1993). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- 4 generations backK955403 Oes Laparo-Thoraco Videoscope Type VOlympus America, Inc. · 1996
- 3 generations backK053382 Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation · 2006
- 2 generations backK081173 Endoscopic CO2 Regulation Unit UcrOlympus Medical Systems Corporation · 2008
- 1 generation backK111648 Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · Recalled
- This deviceK190985 BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| −4 | K955403 | Oes Laparo-Thoraco Videoscope Type V | Olympus America, Inc. | 1996 | — |
| −3 | K053382 | Laparo-Thoraco Videoscope XLTF-Vaw | Olympus Medical Systems Corporation | 2006 | — |
| −2 | K081173 | Endoscopic CO2 Regulation Unit Ucr | Olympus Medical Systems Corporation | 2008 | — |
| −1 | K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator | Bracco Diagnostic, Inc. | 2011 | 1 |
| 0 (this device) | K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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 FCX? 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 FCX device
- #1 K262152 VS-370CF, VS-370CTscore 15.3 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorSummary page 5…keted Predicate Device for Claimed Equivalence: Predicate Device: Name: Bracco Diagnostics, Inc. CO2mpact Endoscopic Insufflator™ 510(k) #: K111648 Reference Predicate Device: Name: PARI Trek™ S nebulizer compressor 510(k) #: K060357 4. D… | 2011 |
| † | K060357 | Trek S Nebulizer Compressor | 2006 |
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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111648.
How does its category compare?
All FCX devicesFCX Insufflator, Automatic Carbon-Dioxide For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FCX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FCX
Too few FCX 510(k)s in any year since 2007 to give a median.
Recalls per year · FCX
1in 2013
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FCX
143in 2025
MAUDE reports naming product code FCX, 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 | 5 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 13 |
| 2013 | 1 | — | 1 (1) | 19 |
| 2014 | 2 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 54 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 143 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device.
The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.
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/K190985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190985: BAROnova Insufflation System, BAROnova Accessory Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190985
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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