510(k) · Cleared
ClearedPENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Nov 16, 2022 as substantially equivalent to K172156 (Pentax Medical, 2018) and 2 other predicates after a 272-day review. Its family tree reaches back 10 generations to 1993. 2 of the 27 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Nov 16, 2022
- Review
- 272 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K931154 (1993). 25 ancestors in all, the oldest K850978 (1985). 1 later device descends from it, 1 citing it directly. 2 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations between
- 3 generations backK162151 PENTAX Medical ENT Video Imaging SystemPentax of America, Inc. · 2017
- 2 generations backK172156 PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical · 2018
- 1 generation backK182846 PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc. · 2019
- This deviceK220465 PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10…Pentax of America, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK243380 Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation · 2025
Show all 10 generations
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 8 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 7 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 6 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 5 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 4 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 3 generations backK162151 PENTAX Medical ENT Video Imaging SystemPentax of America, Inc. · 2017
- 2 generations backK172156 PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical · 2018
- 1 generation backK182846 PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc. · 2019
- This deviceK220465 PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10…Pentax of America, Inc. · 2022
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −9 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −8 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −7 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −6 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −5 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −4 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −3 | K162151 | PENTAX Medical ENT Video Imaging System | Pentax of America, Inc. | 2017 | — |
| −2 | K172156 | PENTAX Medical EPK-3000 Video Imaging System | Pentax Medical | 2018 | — |
| −1 | K182846 | PENTAX Medical EPK-3000 Video Imaging System | Pentax of America, Inc. | 2019 | — |
| 0 (this device) | K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX… | Pentax of America, Inc. | 2022 | — |
| +1 | K243380 | Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500) | Olympus Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
2 devices in this family have a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K172156 | PENTAX Medical EPK-3000 Video Imaging SystemSummary page 6…Clearance Number PENTAX Medical PENTAX Medical EPK-3000 Video Imaging EPK-3000 Video Imaging K172156, K182846 System System PENTAX Medical PENTAX Medical ENT Video Imaging… | 2018 |
| * | K182846 | PENTAX Medical EPK-3000 Video Imaging SystemSummary page 6…Clearance Number PENTAX Medical PENTAX Medical EPK-3000 Video Imaging EPK-3000 Video Imaging K172156, K182846 System System PENTAX Medical PENTAX Medical ENT Video Imaging System EN… | 2019 |
| * | K183691 | PENTAX Medical ENT Video Imaging SystemSummary page 6…System System PENTAX Medical PENTAX Medical ENT Video Imaging System ENT Video Imaging System K183691 Page 2 of 7 K220465 PENTAX Medical Imaging System… | 2019 |
| † | K142249 | Schoelly Sinuscope | 2015 |
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 |
|---|---|---|---|
| K243380 | Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500) | 2025 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 12 of the 25 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K243380 (Olympus Medical Systems Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172156.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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?
PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL8-J1O, VNL1-J10, and VNL15-J1O endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy. The PENTAX Medical EPK-3000 Video Processor includes PENTAX…
Read the full statement (167 words)
PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL8-J1O, VNL1-J10, and VNL15-J1O endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-3000 Video Processor includes PENTAX i-ScanTm, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL-1570STK, VNL8-J10, VNL11- J10, and VNL15-J1O endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i- Scann, a digital, post-processing imaging enhancement technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220465: PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220465
Report an extraction error
Are you the manufacturer?
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