510(k) · Cleared
ClearedEVA5 Insufflator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palliare, Ltd. · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on Mar 24, 2023 as substantially equivalent to K193520 (Palliare, Ltd., 2020) and 1 other predicate after a 30-day review. Its family tree reaches back 12 generations to 1997. 3 of the 36 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Mar 24, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K964171 (1997). 34 ancestors in all, the oldest K903419 (1990). 1 later device descends from it, 1 citing it directly. 3 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 8 generations between
- 3 generations backK193520 EVA 15 InsufflatorPalliare, Ltd. · 2020
- 2 generations backK202799 EVA15Palliare, Ltd. · 2020
- 1 generation backK222901 EVA15 insufflatorPalliare, Ltd. · 2023
- This deviceK230474 EVA5 InsufflatorPalliare, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK262152 VS-370CF, VS-370CTVISION MEDICAL Co., Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 11 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 10 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
- 9 generations backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- 8 generations backK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- 7 generations backK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
- 6 generations backK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
- 5 generations backK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
- 4 generations backK172516 SurgiQuest AIRSEAL iFS SystemConmed Corporation · 2018
- 3 generations backK193520 EVA 15 InsufflatorPalliare, Ltd. · 2020
- 2 generations backK202799 EVA15Palliare, Ltd. · 2020
- 1 generation backK222901 EVA15 insufflatorPalliare, Ltd. · 2023
- This deviceK230474 EVA5 InsufflatorPalliare, Ltd. · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −11 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −10 | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | 1 |
| −9 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| −8 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| −7 | K110294 | High Flow Insufflation Unit Uhi-4 | Olympus Medical Systems Corporation | 2011 | Class I |
| −6 | K122180 | High Flow Insufflantion Unit | Olympus Medical Systems Corporation | 2012 | Class I |
| −5 | K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015 | 11 |
| −4 | K172516 | SurgiQuest AIRSEAL iFS System | Conmed Corporation | 2018 | — |
| −3 | K193520 | EVA 15 Insufflator | Palliare, Ltd. | 2020 | — |
| −2 | K202799 | EVA15 | Palliare, Ltd. | 2020 | — |
| −1 | K222901 | EVA15 insufflator | Palliare, Ltd. | 2023 | — |
| 0 (this device) | K230474 | EVA5 Insufflator | Palliare, Ltd. | 2023 | — |
| +1 | K262152 | VS-370CF, VS-370CT | VISION MEDICAL Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 1 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
3 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K193520 | EVA 15 InsufflatorSummary page 4…FCX – Insufflator, Automatic Carbon-Dioxide Regulation Number: Product For Endoscope Code: K193520 – Palliare EVA15 CO2 insufflator Primary Predicate Device: 21 CFR 876… | 2020 |
| * | K222901 | EVA15 insufflatorSummary page 4…HIF – Insufflator, Automatic Carbon-Dioxide For Regulation Number: Product Endoscope Code: K222901 – Palliare EVA15 CO2 insufflator Secondary Predicate Device: 21 CFR 8… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262152 | VS-370CF, VS-370CT | 2026 | 0 |
Has anything in its family been recalled? (3 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.
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 34 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K262152 (VISION MEDICAL Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K193520.
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. 2023, 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 EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230474: EVA5 Insufflator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230474
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