510(k) · Cleared
ClearedKsea Medi Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GCT Light Source, Endoscope, Xenon Arc
Cleared on Sep 29, 2003 after a 427-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Sep 29, 2003
- Review
- 427 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK022490 Ksea Medi PackKARL STORZ Endoscopy-America, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK071292 View MD Office System, Model 41066.5540Richard Wolf Medical Instruments Corp. · 2007
Most influential descendants
Showing 1 of 1 · See all- K071292View MD Office System, Model 41066.5540Richard Wolf Medical Instruments Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022490 | Ksea Medi Pack | KARL STORZ Endoscopy-America, Inc. | 2003 | — |
| +1 | K071292 | View MD Office System, Model 41066.5540 | Richard Wolf Medical Instruments Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 GCT? 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K071292 | View MD Office System, Model 41066.5540 | 2007 | 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?
- Of its descendants, K071292 (Richard Wolf Medical Instruments Corp., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GCT devicesGCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GCT
Too few GCT 510(k)s in any year since 2007 to give a median.
Recalls per year · GCT
No recall names GCT since 2007.
Adverse event reports per year · GCT
347in 2025
MAUDE reports naming product code GCT, 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 | 32 |
| 2008 | 1 | — | 0 | 29 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 1 | — | 0 | 21 |
| 2011 | 0 | — | 0 | 132 |
| 2012 | 0 | — | 0 | 36 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 149 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 0 | 200 |
| 2024 | 0 | — | 0 | 296 |
| 2025 | 0 | — | 0 | 347 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medi Pack is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures.
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/K022490 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022490: Ksea Medi Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022490
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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