510(k) · Cleared
ClearedTelepack +
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Dec 20, 2019 as substantially equivalent to K182696 (KARL STORZ Endoscopy-America, Inc., 2018) after a 25-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Dec 20, 2019
- Review
- 25 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070716 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK070716 Image 1 Video Imaging System with Optional Insufflators ControlKARL STORZ Endoscopy-America, Inc. · 2007
- 1 generation backK182696 Telepack X LEDKARL STORZ Endoscopy-America, Inc. · 2018
- This deviceK193235 Telepack +Karl Storz Endoscopy America, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK221174 Telepack +Karl Storz Endoscopy America, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221174Telepack +Karl Storz Endoscopy America, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070716 | Image 1 Video Imaging System with Optional Insufflators Control | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| −1 | K182696 | Telepack X LED | KARL STORZ Endoscopy-America, Inc. | 2018 | — |
| 0 (this device) | K193235 | Telepack + | Karl Storz Endoscopy America, Inc. | 2019 | — |
| +1 | K221174 | Telepack + | Karl Storz Endoscopy America, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 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 |
|---|---|---|---|
| * | K182696 | Telepack X LEDSummary page 4…on Classification Name: Endoscope and accessories : Product FET Code: Regulation: 21 CFR 876.1500 (Endoscope and Accessories) Predicate Telepack X LED (K182696) – Primary Device(s): Reference Flexible Video Cytoscope HD-View (K191357); Image1 SPIES System Device(s): (K160044); I… | 2018 |
| † | K191357 | Flexible HD Cysto-Urethroscope System | 2019 |
| † | K160044 | Image1 SPIES System | 2016 |
| † | K131953 | IMAGE1 Spies | 2013 |
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 |
|---|---|---|---|
| K221174 | Telepack + | 2022 | 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221174 (Karl Storz Endoscopy America, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic 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/K193235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193235: Telepack +.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193235
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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