510(k) · Cleared
ClearedKsea Electronic CO2 Endoflator LC, Model 26430320-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HIF Insufflator, Laparoscopic
Cleared on Mar 30, 2009 as substantially equivalent to K963423 (Karl Storz Endoscopy, 1997) and 1 other predicate after a 369-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 30, 2009
- Review
- 369 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962863 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK962863 Karl Storz Model 264305-20 Electronic EndoflatorKARL STORZ Endoscopy-America, Inc. · 1996
- This deviceK080852 Ksea Electronic CO2 Endoflator LC, Model 26430320-1KARL STORZ Endoscopy-America, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962863 | Karl Storz Model 264305-20 Electronic Endoflator | KARL STORZ Endoscopy-America, Inc. | 1996 | — |
| 0 (this device) | K080852 | Ksea Electronic CO2 Endoflator LC, Model 26430320-1 | KARL STORZ Endoscopy-America, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K963423 | Ksea CO2 EndoflatorSummary page 1…fflator Classification Name: Laparoscopic insufflator Regulation Number: 21 CFR 884.1730 Product Code: HIF Predicate Device(s): KSEA CO2 ENDOFLATOR (K963423) Karl Storz Model 264305-20 Electronic ENDOFLATOR (K962863) Device Description: The KSEA Electronic CO… | 1997 |
| * | K962863 | Karl Storz Model 264305-20 Electronic EndoflatorSummary page 1…1 CFR 884.1730 Product Code: HIF Predicate Device(s): KSEA CO2 ENDOFLATOR (K963423) Karl Storz Model 264305-20 Electronic ENDOFLATOR (K962863) Device Description: The KSEA Electronic CO 2 ENDOFLATOR LC is an insufflation device for universal ap… | 1996 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 KSEA Electronic C02 ENDOFLATOR LC provides C02 gas distention of the abdomen (pneumoperitoneum) for diagnostic or operative laparoscopy. See the instruction manual for your laparoscope for special indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080852: Ksea Electronic CO2 Endoflator LC, Model 26430320-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080852
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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