510(k) · Cleared
ClearedAutomated Endoscope Leak Tester
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · PCV Endoscopic Leak Tester
Cleared on Feb 4, 2013 as substantially equivalent to K093718 (Zutron Medical, LLC, 2010) and 1 other predicate after a 63-day review. Its family tree reaches back 5 generations to 1993. 1 of the 10 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Feb 4, 2013
- Review
- 63 days
- Class
- Class II
- Product code
- PCV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931154 (1993). 8 ancestors in all, the oldest K904799 (1991). 1 later device descends from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 4 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 3 generations backK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003 · Recalled (Class I)
- 2 generations backK033225 Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its…Olympus Optical Co., Ltd. · 2003 · Recalled
- 1 generation backK051886 Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation · 2005
- This deviceK123704 Automated Endoscope Leak TesterOlympus Medical Systems Corp. · 2013
- Descendant · cites it directly · 0 of its ownK212201 PENTAX Medical Auto Leakage Tester SHA-P6Pentax of America, Inc. · 2021
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…3 generations back · 2003
Most influential descendants
Showing 1 of 1 · See all- K212201PENTAX Medical Auto Leakage Tester SHA-P6Pentax of America, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −4 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −3 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| −2 | K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and… | Olympus Optical Co., Ltd. | 2003 | 5 |
| −1 | K051886 | Olympus Choledochoscope, Model XCHF-BP160F | Olympus Medical Systems Corporation | 2005 | — |
| 0 (this device) | K123704 | Automated Endoscope Leak Tester | Olympus Medical Systems Corp. | 2013 | — |
| +1 | K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | Pentax of America, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
1 device in this family has 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 PCV device
- #1 K212201 PENTAX Medical Auto Leakage Tester SHA-P6score 3.6 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K093718 | Zutron Medical Endoscope Leak Tester Model Zutr-10003Summary page 2…it MU-i ___________________ZUTR-10003 _ __________ * 510(k) No. K093718 K051 886 * Manufacturer Zutron Medical… | 2010 |
| * | K051886 | Olympus Choledochoscope, Model XCHF-BP160FSummary page 2…10003 _ __________ * 510(k) No. K093718 K051 886 * Manufacturer Zutron Medical SHIRAKAWA OLYMPUS CO.,… | 2005 |
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 |
|---|---|---|---|
| K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | 2021 | 0 |
Has anything in its family been recalled? (1 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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 3 generations back · ◆ on the line of descent in FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212201 (Pentax of America, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PCV devicesPCV Endoscopic Leak Tester: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PCV
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PCV
Too few PCV 510(k)s in any year since 2007 to give a median.
Recalls per year · PCV
No recall names PCV since 2007.
Adverse event reports per year · PCV
2in 2021
MAUDE reports naming product code PCV, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This equipment is intended to be used to perform and record leakage testing on Olympus flexible endoscopes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123704: Automated Endoscope Leak Tester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123704
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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