510(k) · Cleared
ClearedClarus Murphypen Endoscope (2127-XXX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarus Medical Systems, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Sep 11, 1996 as substantially equivalent to K912089 (Medical Laser, Inc., 1991) and 1 other predicate after a 91-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Sep 11, 1996
- Review
- 91 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912089 (1991). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912089 Modified Series 2100 EndoscopesMedical Laser, Inc. · 1991
- This deviceK962255 Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK991377 Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999
- Descendant · cites it directly · 0 of its ownK082038 Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK080780 Anchorage Scope, Model 000003Epitek, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK993445 Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999
Most influential descendants
Showing 4 of 4 · See all- K991377Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999 · cites it directly2descendants
- K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC · 2009 · cites it directly0descendants
- K080780Anchorage Scope, Model 000003Epitek, Inc. · 2008 · 2 generations on0descendants
- K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912089 | Modified Series 2100 Endoscopes | Medical Laser, Inc. | 1991 | — |
| 0 (this device) | K962255 | Clarus Murphypen Endoscope (2127-XXX) | Clarus Medical Systems, Inc. | 1996 | — |
| +1 | K991377 | Omnisonics Flexible Fiber Optic Endoscope and Coupler | Omnisonics Medical Technologies | 1999 | — |
| +1 | K082038 | Clarus Video Airway Endoscope, Models 30000-V and 30003-V | Clarus Medical, LLC | 2009 | — |
| +2 | K080780 | Anchorage Scope, Model 000003 | Epitek, Inc. | 2008 | — |
| +2 | K993445 | Omnisonic Endoscopic Deflector | Omnisonics Medical Technologies | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 EOB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K912089 | Modified Series 2100 EndoscopesSummary page 2…ckaging and sterilization methods are equivalent to Model 2126, 2120, and Model 2125. The Model 2127 will fall within the Clarus 2100 Series of endoscopes as filed under K912089 which is cleared for reuse. Models 2126 and 2240 endoscope as filed under K934432 are also cleared for reuse. The clinical indic… | 1991 |
| * | K934432 | Otoview Endoscopy SystemSummary page 2…25. The Model 2127 will fall within the Clarus 2100 Series of endoscopes as filed under K912089 which is cleared for reuse. Models 2126 and 2240 endoscope as filed under K934432 are also cleared for reuse. The clinical indications for use are similar to those of the Rapiscope Optical Fiber endoscope by Co… | 1994 |
| * | — | Model 2126 SpinePEN Endoscope Named without a submission number | |
| * | — | Model 2120 NeuroPEN Endoscope Named without a submission number | |
| * | — | Model 2125 MurphyScope Named without a submission number | |
| * | — | Model 2400 InstrumentScope Named without a submission number | |
| * | — | Model 2240 Otoscope Named without a submission number | |
| * | — | Model Number C-DFO-1.6-40-Radiscope™ Optical Fiber Named without a submission number | |
| * | — | Model S1002 Diaguide Named without a submission number | |
| * | — | Model SLS Endoscope Named without a submission number |
What descends from it? (4)
2 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K991377 (Omnisonics Medical Technologies, 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
The Clarus Model 2126 SpinePEN is intended for diagnostic accessing and visualizing tissue during cranial sinus, laryngopharyngeal and bronchial procedures. It is not intended for intraoperative or percutaneous use. The endoscope is reusable and is packaged with five disposable cannulae.
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/K962255 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962255: Clarus Murphypen Endoscope (2127-XXX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962255
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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