510(k) · Cleared
ClearedSynthes Light Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · FQP Lamp, Operating-Room
Cleared on Dec 6, 1999 as substantially equivalent to K971057 (Cogent Light Technologies, Inc., 1997) after a 63-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 6, 1999
- Review
- 63 days
- Class
- Class II
- Product code
- FQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971057 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971057 Cogenlight Technologies XLS Illuminator SystemCogent Light Technologies, Inc. · 1997
- This deviceK993314 Synthes Light GuideSynthes (Usa) · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971057 | Cogenlight Technologies XLS Illuminator System | Cogent Light Technologies, Inc. | 1997 | — |
| 0 (this device) | K993314 | Synthes Light Guide | Synthes (Usa) | 1999 | — |
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 FQP? 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? (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 |
|---|---|---|---|
| * | K971057 | Cogenlight Technologies XLS Illuminator SystemSummary page 1…tember 22,1999 Proprietary Name: Synthes Light Guide Common Name: Light Source Accessory RA-01 Classification Name: 21 CFR §878.4580 (surgical lamp) Predicate Device: K971057 - Cogent Light XLS llluminator System Cogent Light Technologies, Inc. 26145 Technology Drive Santa Clarita, CA 91355-1137 Desc… | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FQP devicesFQP Lamp, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FQP
FDA has decided no FQP device since 2007.
Median 510(k) review, days · FQP
Too few FQP 510(k)s in any year since 2007 to give a median.
Recalls per year · FQP
No recall names FQP since 2007.
Adverse event reports per year · FQP
19in 2025
MAUDE reports naming product code FQP, 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 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes Light Guide is intended to transmit light to illuminate a surgical site during surgical 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/K993314 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993314: Synthes Light Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993314
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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