510(k) · Cleared
ClearedCarbonaid C02 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 Jun 22, 2012 as substantially equivalent to K052125 (Cardia Innovation AB, 2006) after a 261-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Jun 22, 2012
- Review
- 261 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030469 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK030469 Laparoshield Conditioned Insufflation SetPall Medical · 2003
- 1 generation backK052125 Carbonaid Gas DiffuserCardia Innovation AB · 2006
- This deviceK112975 Carbonaid C02 DiffuserCardia Innovation AB · 2012
- Descendant · cites it directly · 0 of its ownK173545 TEMED Gas DiffuserTemed · 2018
Most influential descendants
Showing 1 of 1 · See all- K173545TEMED Gas DiffuserTemed · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030469 | Laparoshield Conditioned Insufflation Set | Pall Medical | 2003 | — |
| −1 | K052125 | Carbonaid Gas Diffuser | Cardia Innovation AB | 2006 | — |
| 0 (this device) | K112975 | Carbonaid C02 Diffuser | Cardia Innovation AB | 2012 | — |
| +1 | K173545 | TEMED Gas Diffuser | Temed | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K052125 | Carbonaid Gas DiffuserSummary page 2…Date Indications __________Number Cleared _ ______ Cardia Innovation K052 125 2/8/2006 intended for use by AB… | 2006 |
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 |
|---|---|---|---|
| K173545 | TEMED Gas Diffuser | 2018 | 0 |
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?
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 CarbonAid® CO 2 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 which can result in organ damage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112975 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112975: Carbonaid C02 Diffuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112975
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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