510(k) · Decided
DecidedBAROnova Access Sheath Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baronova, Inc. · QGG Esophageal Sheath With Distal Balloon Anchor
Cleared on Jul 22, 2019 as substantially equivalent to K181451 (Olympus Medical Systems Corp., 2019) and 2 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1986. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 22, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- QGG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K853585 (1986). 14 ancestors in all. No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 5 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 4 generations backK051645 Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005 · Recalled
- 3 generations backK072957 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2008 · Recalled
- 2 generations backK172246 Olympus Urf-V2/V2ROlympus Medical Systems Corp. · 2018 · Recalled
- 1 generation backK181451 Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope…Olympus Medical Systems Corp. · 2019 · Recalled
- This deviceK191078 BAROnova Access Sheath KitBaronova, Inc. · 2019
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope3 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −5 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −4 | K051645 | Evis Exera 160A System | Olympus Medical Systems Corporation | 2005 | 3 |
| −3 | K072957 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2008 | 1 |
| −2 | K172246 | Olympus Urf-V2/V2R | Olympus Medical Systems Corp. | 2018 | 3 |
| −1 | K181451 | Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus… | Olympus Medical Systems Corp. | 2019 | 1 |
| 0 (this device) | K191078 | BAROnova Access Sheath Kit | Baronova, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 1 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2018 | 2 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K181451 | Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7RSummary page 4…lly Marketed Predicate Device for Claimed Equivalence: Primary Predicate: Name: BAROnova Access Sheath Accessory Classification #: Q181451 Secondary Predicates: Name: Seal Cap 510(k) #: K172575 Name:… | 2019 |
| * | K172575 | BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope CapSummary page 4…BAROnova Access Sheath Accessory Classification #: Q181451 Secondary Predicates: Name: Seal Cap 510(k) #: K172575 Name: Hypodermic Syringe 510(k) #: K980987 4. Device Description The BAROno… | 2018 |
| * | K980987 | Becton Dickinson SyringeSummary page 4…dary Predicates: Name: Seal Cap 510(k) #: K172575 Name: Hypodermic Syringe 510(k) #: K980987 4. Device Description The BAROnova Access Sheath Kit includes the following products: • BAROnova Access She… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 9.5 years on median.
- 11 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All QGG devicesQGG Esophageal Sheath With Distal Balloon Anchor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QGG
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QGG
Too few QGG 510(k)s in any year since 2007 to give a median.
Recalls per year · QGG
No recall names QGG since 2007.
Adverse event reports per year · QGG
No MAUDE report names QGG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BAROnova Access Sheath Kit is used in conjunction with an endoscope for procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract, with or without instruments through the instrument channel of the endoscope.
The BAROnova Access Sheath Kit is used in conjunction with the TransPyloric Shuttle Delivery Device to facilitate insertion and positioning of the device during TPS delivery and deployment.
The Access Sheath Kit is NOT indicated for foreign body removal or instrument use alongside the endoscope.
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/K191078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191078: BAROnova Access Sheath Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191078
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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