510(k) · Cleared
ClearedPolaris 100/200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager Medical GmbH · FTD Lamp, Surgical
Cleared on Mar 8, 2013 as substantially equivalent to K010724 (Drager Medizintechnik GmbH, 2001) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 8, 2013
- Review
- 88 days
- Class
- Class II
- Product code
- FTD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K965130 (1997). 4 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 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −2 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −1 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| 0 (this device) | K123776 | Polaris 100/200 | Drager Medical GmbH | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 FTD? 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 |
|---|---|---|---|
| * | K010724 | Sola 700,Sola 500, Sola 300Summary page 3…olaris 200 light Leal marketed devices: Dr~iger is claimning..substantial equivalence of its Polaris 100/200 surgical light to the Sola 700, Sola 500 from Drager (1(010724) and to the device ILED from Trumpf Medizin Systemne (k061317).- TechnologicalCharacteristics: Performance testing was condu… | 2001 |
| * | K061317 | ILEDSummary page 3…ning..substantial equivalence of its Polaris 100/200 surgical light to the Sola 700, Sola 500 from Drager (1(010724) and to the device ILED from Trumpf Medizin Systemne (k061317).- TechnologicalCharacteristics: Performance testing was conducted to verify that the proposed Polaris 100/200 Surgical lamp… | 2006 |
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 16 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FTD
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FTD
70in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTD
6in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTD
81in 2025
MAUDE reports naming product code FTD, 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 | — | 11 | 7 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 9 | 22 |
| 2010 | 2 | — | 3 | 21 |
| 2011 | 1 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 3 | 70 | 0 | 29 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 1 | 18 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 105 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 136 |
| 2023 | 0 | — | 6 | 251 |
| 2024 | 0 | — | 0 | 144 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms.
Double light
The combination of two operating lights as an operating light system enables the use in operating and treatment rooms.
Versions
- Polaris 100 light
- Polaris 200 light
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123776 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123776: Polaris 100/200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123776
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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