510(k) · Cleared
ClearedPentex EC-3890LI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Medical Company · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Dec 28, 2009 as substantially equivalent to K951574 (Pentax Precision Instrument Corp., 1996) after a 90-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Dec 28, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K822846 (1982). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K822846 | Pentax FC-38LA & FC-38SA Colonofiber | Pentax Precision Instrument Corp. | 1982 | — |
| −1 | K951574 | EC-3800L, Video Colonoscope | Pentax Precision Instrument Corp. | 1996 | 3 |
| 0 (this device) | K093037 | Pentex EC-3890LI | Pentax Medical Company | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 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 FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 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 |
|---|---|---|---|
| * | K951574 | EC-3800L, Video ColonoscopeSummary page 1…escription Manufacturer PMN# EC-3800L, Video Colonoscope Pentax Medical Company jK95 1574 EPK-i, Video Processor Pentax Medical Company In submission… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 13.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 7 other devices also cite its predicate K951574.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
The EC-3890L-1, Video Colonoscope is intended to provide optical visualization (via a video monitor) of and therapeutid access to the Lower Gastrointestinal Tract. This anatomy includes but is not restricted to the organs, tissues and subsystems: Large Bowel and Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093037: Pentex EC-3890LI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093037
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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