510(k) · Cleared
ClearedPENTAX Medical ENT Video Imaging System
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 Apr 20, 2017 as substantially equivalent to K061313 (Olympus Medical Systems Corporation, 2006) after a 261-day review. Its family tree reaches back 7 generations to 1993. 2 of the 28 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Apr 20, 2017
- Review
- 261 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931154 (1993). 21 ancestors in all, the oldest K850978 (1985). 6 later devices descend from it, 3 citing it directly. 2 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 3 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 2 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 1 generation backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- This deviceK162151 PENTAX Medical ENT Video Imaging SystemPentax of America, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK172156 PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical · 2018
- Descendant · cites it directly · 2 of its ownK183691 PENTAX Medical ENT Video Imaging SystemPentax of America, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK182846 PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK220465 PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10…Pentax of America, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK243380 Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical · 2018 · cites it directly3descendants
- K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc. · 2019 · cites it directly2descendants
- K182846PENTAX Medical EPK-3000 Video Imaging SystemPentax of America, Inc. · 2019 · 2 generations on2descendants
- K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT…Pentax of America, Inc. · 2022 · 2 generations on1descendant
- K243380Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −3 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −2 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −1 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| 0 (this device) | K162151 | PENTAX Medical ENT Video Imaging System | Pentax of America, Inc. | 2017 | — |
| +1 | K172156 | PENTAX Medical EPK-3000 Video Imaging System | Pentax Medical | 2018 | — |
| +1 | K183691 | PENTAX Medical ENT Video Imaging System | Pentax of America, Inc. | 2019 | — |
| +2 | K182846 | PENTAX Medical EPK-3000 Video Imaging System | Pentax of America, Inc. | 2019 | — |
| +2 | K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX… | Pentax of America, Inc. | 2022 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K061313 | Evis Exera 180 SystemSummary page 4…s II Product Code: EOB and PEA III. PREDICATE and REFERENCE DEVICE Trade/Device Name: OLYMPUS EVIS EXERA 180 System The OLYMPUS EVIS EXERA II 180 System (K061313) is the primary predicate for this submission. Trade/Device Name: Pentax Medical EKP-i5010 Video Processor with EB Family The PE… | 2006 |
| † | K143727 | PENTAX Medical EKP-i5010 Video Processor with EB Family | 2015 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ 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 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 12 of the 21 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K172156 (Pentax Medical, 2018) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K061313.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscope, PENTAX Medical Video Processor and other ancillary equipment. 1. PENTAX Medical Video Naso-Pharyngo-Laryngoscope The PENTAX Medical Video Naso-Pharyngo-Laryngoscopes (VNL-1570STK) is designed to be used with a PENTAX Medical video processor, light source, documentation equipment, display monitor, endoscopic accessories, and other ancillary equipment and…
Read the full statement (132 words)
PENTAX Medical ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscope, PENTAX Medical Video Processor and other ancillary equipment.
1. PENTAX Medical Video Naso-Pharyngo-Laryngoscope
The PENTAX Medical Video Naso-Pharyngo-Laryngoscopes (VNL-1570STK) is designed to be used with a PENTAX Medical video processor, light source, documentation equipment, display monitor, endoscopic accessories, and other ancillary equipment and intended to provide optical visualization (via a video monitor) of, and therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.
2. PENTAX Medical Video Processor
The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads, compatible endoscopes, light sources, monitors and other ancillary equipment for ENT endoscopic observation and diagnosis, and naso-pharyngo-laryngoscopic diagnosis, and treatment.
The PENTAX Medical EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162151: PENTAX Medical ENT Video Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162151
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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