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 May 13, 2022 as substantially equivalent to K193235 (Karl Storz Endoscopy America, Inc., 2019) after an 18-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- May 13, 2022
- Review
- 18 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070716 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK070716 Image 1 Video Imaging System with Optional Insufflators ControlKARL STORZ Endoscopy-America, Inc. · 2007
- 2 generations backK182696 Telepack X LEDKARL STORZ Endoscopy-America, Inc. · 2018
- 1 generation backK193235 Telepack +Karl Storz Endoscopy America, Inc. · 2019
- This deviceK221174 Telepack +Karl Storz Endoscopy America, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070716 | Image 1 Video Imaging System with Optional Insufflators Control | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| −2 | K182696 | Telepack X LED | KARL STORZ Endoscopy-America, Inc. | 2018 | — |
| −1 | K193235 | Telepack + | Karl Storz Endoscopy America, Inc. | 2019 | — |
| 0 (this device) | K221174 | Telepack + | Karl Storz Endoscopy America, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K193235 | Telepack +Summary page 4…sories Product Code: FET Regulation: 21 CFR 876.1500 (Endoscope and Accessories) Predicate Device(s): Trade Name: Telepack + (K193235) The Telepack + is a portable and compact all-in-one Device Description:… | 2019 |
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
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. 2022, 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 as stated in the FDA summary.
https://510kreport.com/device/K221174 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221174: Telepack +.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221174
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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