510(k) · Cleared
ClearedNovaprobe Led Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novaprobe Incorporated · FCW Light Source, Fiberoptic, Routine
Cleared on Jul 24, 2014 as substantially equivalent to K082813 (Stryker Corp., 2008) and 3 other predicates after a 450-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jul 24, 2014
- Review
- 450 days
- Class
- Class II
- Product code
- FCW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K961971 (1996). 8 ancestors in all, the oldest K952696 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK961971 Q-5000Stryker Endoscopy · 1996
- 4 generations backK082813 Stryker Led LightsourceStryker Corp. · 2008 · Recalled
- 3 generations backK093792 Led Light SourceSunoptic Technologies, LLC · 2010
- 2 generations backK102167 LO-50 Led Light SourceFiberoptics Technology, Inc. · 2010
- 1 generation backK103813 SOPRO 281Sopro · 2011
- This deviceK131226 Novaprobe Led Light SourceNovaprobe Incorporated · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961971 | Q-5000 | Stryker Endoscopy | 1996 | — |
| −4 | K082813 | Stryker Led Lightsource | Stryker Corp. | 2008 | 1 |
| −3 | K093792 | Led Light Source | Sunoptic Technologies, LLC | 2010 | — |
| −2 | K102167 | LO-50 Led Light Source | Fiberoptics Technology, Inc. | 2010 | — |
| −1 | K103813 | SOPRO 281 | Sopro | 2011 | — |
| 0 (this device) | K131226 | Novaprobe Led Light Source | Novaprobe Incorporated | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2012 | 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 FCW? 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? (4)
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 |
|---|---|---|---|
| * | K082813 | Stryker Led LightsourceSummary page 1…devices to which substantial equivalence is claimed: 510(K) Number Trade or Proprietary or Manufacturer ______________Model Name I K0828 13 1. LED Light Source L9000 1. Stryker Endoscopy 2 K(103813 2. LED Light Souirce 2… | 2008 |
| * | K103813 | SOPRO 281Summary page 3…endoscopic and diagnostic __________procedures SOPRO K103813 Cold Light Sources are L7ED 6000K LED Light Source… | 2011 |
| * | K121724 | Endolight Led 1.1 Endolightled 1.2Summary page 1…1. Stryker Endoscopy 2 K(103813 2. LED Light Souirce 2 SOPRO. _____________SOPRO 281 _ ___________ 3 K121724 3 5160 ENDOLIGHT light 3 Richard Wolf Medical Source… | 2012 |
| * | K093792 | Led Light SourceSummary page 1…121724 3 5160 ENDOLIGHT light 3 Richard Wolf Medical Source Instruments Corporation Inc.. 4 K093 792 4 LLS-050 LED light 4 Sunoptic Technologies Source @ 2014 NovaProbe In… | 2010 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 5 other devices also cite its predicate K082813.
How does its category compare?
All FCW devicesFCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FCW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FCW
Too few FCW 510(k)s in any year since 2007 to give a median.
Recalls per year · FCW
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCW
140in 2025
MAUDE reports naming product code FCW, 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 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 148 |
| 2010 | 1 | — | 0 | 713 |
| 2011 | 0 | — | 4 | 603 |
| 2012 | 2 | — | 0 | 77 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 24 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 76 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 0 | 152 |
| 2021 | 0 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 179 |
| 2024 | 0 | — | 0 | 179 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131226: Novaprobe Led Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131226
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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