510(k) · Cleared
ClearedPENTAX Medical Auto Leakage Tester SHA-P6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · PCV Endoscopic Leak Tester
Cleared on Oct 1, 2021 as substantially equivalent to K123704 (Olympus Medical Systems Corp., 2013) after a 79-day review. Its family tree reaches back 6 generations to 1993. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 1, 2021
- Review
- 79 days
- Class
- Class II
- Product code
- PCV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931154 (1993). 9 ancestors in all, the oldest K904799 (1991). No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 4 generations backK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003 · Recalled (Class I)
- 3 generations backK033225 Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its…Olympus Optical Co., Ltd. · 2003 · Recalled
- 2 generations backK051886 Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation · 2005
- 1 generation backK123704 Automated Endoscope Leak TesterOlympus Medical Systems Corp. · 2013
- This deviceK212201 PENTAX Medical Auto Leakage Tester SHA-P6Pentax of America, Inc. · 2021
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…4 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −5 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −4 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| −3 | K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and… | Olympus Optical Co., Ltd. | 2003 | 5 |
| −2 | K051886 | Olympus Choledochoscope, Model XCHF-BP160F | Olympus Medical Systems Corporation | 2005 | — |
| −1 | K123704 | Automated Endoscope Leak Tester | Olympus Medical Systems Corp. | 2013 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K123704 | Automated Endoscope Leak TesterSummary page 4…1500 g. Regulation Name: Endoscope and accessories h. Regulatory Class: Class II i. Product Code: PCV j. Predicate Device: Automated Endoscope Leak Tester ALT-Y0003 (K123704) k. Reference Device: ZUTRON Medical Endoscope Leak Tester, Model ZUTR-10003 (K093718) l. Device Description: PENTAX Med… | 2013 |
| † | K093718 | Zutron Medical Endoscope Leak Tester Model Zutr-10003 | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ on the line of descent in FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 6.4 years on median.
- 5 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All PCV devicesPCV Endoscopic Leak Tester: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The PENTAX Medical Auto Leakage Tester SHA-P6 is intended to be used to perform leakage testing on PENTAX Medical flexible endoscopes.
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/K212201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212201: PENTAX Medical Auto Leakage Tester SHA-P6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212201
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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