510(k) · Cleared
ClearedArtemis Light Engine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Medical Imaging · NTN Led Light Source
Cleared on Mar 16, 2015 as substantially equivalent to K130819 (Olympus Winter & Ibe GmbH, 2013) and 1 other predicate after a 315-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Mar 16, 2015
- Review
- 315 days
- Class
- Class II
- Product code
- NTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961971 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961971 | Q-5000 | Stryker Endoscopy | 1996 | — |
| −2 | K082813 | Stryker Led Lightsource | Stryker Corp. | 2008 | 1 |
| −1 | K130819 | CLL- V1 Light Source | Olympus Winter & Ibe GmbH | 2013 | — |
| 0 (this device) | K141164 | Artemis Light Engine | Quest Medical Imaging | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 NTN? 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? (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 |
|---|---|---|---|
| * | K130819 | CLL- V1 Light SourceSummary page 4…R 876.1500 Product Code: NTN Identification of Predicate Device(s): 510(k) Device Manufacturer Number K130819 CLLV1, LED Light Source Olympus Winter & Ibe… | 2013 |
| * | K123956 | Power Led 175Summary page 4…Manufacturer Number K130819 CLLV1, LED Light Source Olympus Winter & Ibe GmbH K123956 Power LED 175 Karl Storz GmbH & Co. KG Intended Use Statement The Artemis Light Engine is a… | 2013 |
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 19 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All NTN devicesNTN Led Light Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NTN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NTN
Too few NTN 510(k)s in any year since 2007 to give a median.
Recalls per year · NTN
No recall names NTN since 2007.
Adverse event reports per year · NTN
42in 2025
MAUDE reports naming product code NTN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 47 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 42 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141164: Artemis Light Engine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141164
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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