510(k) · Cleared
ClearedPLS Portable Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optim, Inc. · NTN Led Light Source
Cleared on Jul 28, 2009 as substantially equivalent to K080622 (Optim, Inc., 2008) and 1 other predicate after a 39-day review. Its family tree reaches back 7 generations to 1992. 9 later devices descend from it.
- Decided
- Jul 28, 2009
- Review
- 39 days
- Class
- Class II
- Product code
- NTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921244 (1992). 20 ancestors in all, the oldest K864821 (1987). 9 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 5 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 4 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 3 generations backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- 2 generations backK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- 1 generation backK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- This deviceK091829 PLS Portable Light SourceOptim, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK152435 PassAssist LED Light FiberEntellus Medical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK212774 VenSure LightGuideIntersect Ent. · 2022
- Descendant · 4 generations on · 0 of its ownK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130503Pathassist Led Light FiberEntellus Medical, Inc. · 2013 · cites it directly6descendants
- K141916Pathassist Led Light FiberEntellus Medical, Inc. · 2014 · 2 generations on5descendants
- K152435PassAssist LED Light FiberEntellus Medical, Inc. · 2015 · 3 generations on2descendants
- K212774VenSure LightGuideIntersect Ent. · 2022 · 3 generations on1descendant
- K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −6 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −5 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −4 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −3 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −2 | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System… | Vision-Sciences, Inc. | 2007 | — |
| −1 | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | Optim, Inc. | 2008 | — |
| 0 (this device) | K091829 | PLS Portable Light Source | Optim, Inc. | 2009 | — |
| +1 | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| +2 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
| +3 | K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015 | — |
| +3 | K212774 | VenSure LightGuide | Intersect Ent. | 2022 | — |
| +4 | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System… | Fiagon GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105Summary page 1…Common or Usual Name LED Light Source Classification Name and Product Code LED Light Source; NTN Predicate Devices ENTity NasoView Fiberscope, K080622 SOPRO 225 Dual Halogen Light Source, K072912 Purpose of the Abbreviated 510(k) Notice The PLS is a modification of… | 2008 |
| * | K072912 | Sopro 225 Dual Halogen Light SourceSummary page 1…sification Name and Product Code LED Light Source; NTN Predicate Devices ENTity NasoView Fiberscope, K080622 SOPRO 225 Dual Halogen Light Source, K072912 Purpose of the Abbreviated 510(k) Notice The PLS is a modification of the light source embedded into the ENTity Nas… | 2007 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K130503 (Entellus Medical, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K080622.
How does its category compare?
All NTN devicesNTN Led Light Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091829 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091829: PLS Portable Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091829
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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