510(k) · Cleared
ClearedCarbonaid Gas Diffuser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardia Innovation AB · HIF Insufflator, Laparoscopic
Cleared on Feb 8, 2006 as substantially equivalent to K030469 (Pall Medical, 2003) after a 187-day review. Its family tree reaches back 1 generation to 2003. 13 later devices descend from it.
- Decided
- Feb 8, 2006
- Review
- 187 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030469 (2003). 13 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK030469 Laparoshield Conditioned Insufflation SetPall Medical · 2003
- This deviceK052125 Carbonaid Gas DiffuserCardia Innovation AB · 2006
- Descendant · cites it directly · 9 of its ownK090456 InsuflowLexion Medical, LLC · 2009
- Descendant · 2 generations on · 5 of its ownK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
- Descendant · 3 generations on · 3 of its ownK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
- Descendant · 3 generations on · 2 of its ownK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK101320 VasovaporLexion Medical, LLC · 2010
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090456InsuflowLexion Medical, LLC · 2009 · cites it directly9descendants
- K120640Insuflow Synergy PortLexion Medical, LLC · 2012 · 2 generations on5descendants
- K132204Insuflow Synergy XL PortLexion Medical, LLC · 2013 · 3 generations on3descendants
- K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014 · 3 generations on2descendants
- K101320VasovaporLexion Medical, LLC · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030469 | Laparoshield Conditioned Insufflation Set | Pall Medical | 2003 | — |
| 0 (this device) | K052125 | Carbonaid Gas Diffuser | Cardia Innovation AB | 2006 | — |
| +1 | K090456 | Insuflow | Lexion Medical, LLC | 2009 | — |
| +2 | K120640 | Insuflow Synergy Port | Lexion Medical, LLC | 2012 | — |
| +3 | K132204 | Insuflow Synergy XL Port | Lexion Medical, LLC | 2013 | — |
| +3 | K140263 | Insuflow Synergy Port, Insuflow Synergy XL Port | Lexion Medical, LLC | 2014 | — |
| +2 | K101320 | Vasovapor | Lexion Medical, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 HIF? 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 HIF device
- #1 K250388 Endoflator +score 15.8 · 10 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 |
|---|---|---|---|
| * | K030469 | Laparoshield Conditioned Insufflation SetSummary page 1…Carbon Dioxide Gas Insufflator PREDICATE DEVICE: Pall Medical Laparosliield Conditioned Insufflation Set; K030469 Device Description: The CarbonAidr m gas diffuser is a disposable surgical device for effective insufflation of carbon dioxid… | 2003 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K090456 (Lexion Medical, LLC, 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIF
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIF
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HIF
1,507in 2025
MAUDE reports naming product code HIF, 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 | 4 | 140 | 0 | 8 |
| 2008 | 2 | — | 1 | 14 |
| 2009 | 4 | 191 | 0 | 21 |
| 2010 | 2 | — | 0 | 41 |
| 2011 | 5 | 128 | 0 | 44 |
| 2012 | 5 | 138 | 0 | 38 |
| 2013 | 2 | — | 0 | 40 |
| 2014 | 2 | — | 0 | 43 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 3 | 88 | 1 | 72 |
| 2017 | 5 | 242 | 0 | 68 |
| 2018 | 3 | 207 | 1 | 97 |
| 2019 | 2 | — | 0 | 128 |
| 2020 | 4 | 64 | 0 | 360 |
| 2021 | 1 | — | 0 | 654 |
| 2022 | 1 | — | 0 | 667 |
| 2023 | 7 | 134 | 1 (1) | 890 |
| 2024 | 4 | 170 | 0 | 1,483 |
| 2025 | 3 | 210 | 0 | 1,507 |
| 2026 | 3 | 265 | 12 | — |
What is it indicated for?
The CarbonAidTM gas diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052125: Carbonaid Gas Diffuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052125
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