510(k) · Cleared
ClearedSOPRO 281
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Mar 22, 2011 as substantially equivalent to K102167 (Fiberoptics Technology, Inc., 2010) and 1 other predicate after an 83-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Mar 22, 2011
- Review
- 83 days
- Class
- Class II
- Product code
- NTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K961971 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK961971 Q-5000Stryker Endoscopy · 1996
- 3 generations backK082813 Stryker Led LightsourceStryker Corp. · 2008 · Recalled
- 2 generations backK093792 Led Light SourceSunoptic Technologies, LLC · 2010
- 1 generation backK102167 LO-50 Led Light SourceFiberoptics Technology, Inc. · 2010
- This deviceK103813 SOPRO 281Sopro · 2011
- Descendant · cites it directly · 0 of its ownK131226 Novaprobe Led Light SourceNovaprobe Incorporated · 2014
Most influential descendants
Showing 1 of 1 · See all- K131226Novaprobe Led Light SourceNovaprobe Incorporated · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961971 | Q-5000 | Stryker Endoscopy | 1996 | — |
| −3 | K082813 | Stryker Led Lightsource | Stryker Corp. | 2008 | 1 |
| −2 | K093792 | Led Light Source | Sunoptic Technologies, LLC | 2010 | — |
| −1 | K102167 | LO-50 Led Light Source | Fiberoptics Technology, Inc. | 2010 | — |
| 0 (this device) | K103813 | SOPRO 281 | Sopro | 2011 | — |
| +1 | K131226 | Novaprobe Led Light Source | Novaprobe Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K102167 | LO-50 Led Light SourceSummary page 1…of Predicate Device Device Applicant 510(k) No Date cleared LO-50 LED Light Source Fiberoptics Technology inc K102167 08/17/2010 LLS-050 Sunoptic technologie K093792 03/18/2010 The SOPRO 281 is… | 2010 |
| * | K093792 | Led Light SourceSummary page 1…k) No Date cleared LO-50 LED Light Source Fiberoptics Technology inc K102167 08/17/2010 LLS-050 Sunoptic technologie K093792 03/18/2010 The SOPRO 281 is substantially equivalent to the predicate devices by the Fiberoptics Technology… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131226 | Novaprobe Led Light Source | 2014 | 0 |
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 5 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K131226 (Novaprobe Incorporated, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102167.
How does its category compare?
All NTN devicesNTN Led Light Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103813: SOPRO 281.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103813
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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