510(k) Report

510(k) · Cleared

Cleared

Pentax FC-38LA & FC-38SA Colonofiber

K822846510(k) TraditionalCleared Oct 22, 198229-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pentax Precision Instrument Corp. · FDF Colonoscope And Accessories, Flexible/Rigid

Cleared on Oct 22, 1982 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 76 later devices descend from it.

Decided
Oct 22, 1982
Review
29 days
Class
Class II
Product code
FDF
Recalls
None
Predicates
0

76 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 9 descendants cleared1997: 1 descendant cleared2004: 2 descendants cleared2009: 2 descendants cleared2007: 2 descendants cleared2008: 1 descendant cleared2006: 2 descendants cleared2010: 3 descendants cleared2012: 7 descendants cleared2005: 1 descendant cleared2002: 1 descendant cleared2011: 2 descendants cleared2015: 3 descendants cleared2014: 6 descendants cleared2017: 5 descendants cleared2026: 1 descendant cleared2016: 6 descendants cleared2019: 4 descendants cleared2013: 2 descendants cleared2020: 4 descendants cleared2018: 3 descendants cleared2024: 2 descendants cleared2025: 1 descendant cleared2021: 2 descendants cleared2022: 3 descendants cleared2023: 1 descendant cleared19801990200020102020
  1. This deviceK822846 Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp. · 1982
  2. Descendant · cites it directly · 72 of its ownK951574 EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
  3. Descendant · cites it directly · 42 of its ownK951579 EC-3800TL, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
  4. Descendant · 2 generations on · 39 of its ownK961570 Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes…Pentax Precision Instrument Corp. · 1996 · Recalled
  5. Descendant · 2 generations on · 39 of its ownK961563 EC-384OTL, Video ColonscopePentax Precision Instrument Corp. · 1996
  6. Descendant · 2 generations on · 38 of its ownK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

1996: 91997: 12002: 12004: 22005: 12006: 22007: 22008: 12009: 22010: 32011: 22012: 72013: 22014: 62015: 32016: 62017: 52018: 32019: 42020: 42021: 22022: 32023: 12024: 22025: 12026: 1
1996high 9 (1996) · low 0 (1998)2026

Most influential descendants

Showing 5 of 76 · See all
  • K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · cites it directly72descendants
  • K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp. · 1996 · cites it directly42descendants
  • K961570Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)Pentax Precision Instrument Corp. · 1996 · 2 generations on39descendants
  • K961563EC-384OTL, Video ColonscopePentax Precision Instrument Corp. · 1996 · 2 generations on39descendants
  • K032688Colonosight Model 510BSightline Technologies, Ltd. · 2004 · 2 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K822846Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp.1982—
+1K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp.19963
+1K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp.19961
+2K961570Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)Pentax Precision Instrument Corp.19961
+2K961563EC-384OTL, Video ColonscopePentax Precision Instrument Corp.1996—
+2K032688Colonosight Model 510BSightline Technologies, Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199690
199710
200210
200420
200510
200620
200720
200810
200920
201030
201120
201270
201320
201460
201530
201660
201750
201830
201940
202040
202120
202230
202310
202420
202510
202610
FIG. 1 — Lineage of K822846, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (76)

See all 76

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp.199672
K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp.199642

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?

  • Of its descendants, K951574 (Pentax Precision Instrument Corp., 1996) has gone furthest, with 72 descendants of its own.

How does its category compare?

All FDF devices

FDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDF

4in 2025

2007: 42008: 22009: 62010: 42011: 22012: 72013: 22014: 62015: 22016: 72017: 42018: 72019: 42020: 42021: 32022: 52023: 62024: 22025: 42026 (partial year): 5
2007high 7 (2012) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDF

194in 2025

2007: 70 days median2009: 91 days median2010: 101 days median2012: 241 days median2014: 164 days median2016: 98 days median2017: 36 days median2018: 101 days median2019: 56 days median2020: 250 days median2021: 30 days median2022: 147 days median2023: 203 days median2025: 194 days median2026 (partial year): 147 days median
2007high 250 (2020) · low 30 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FDF

8in 2023

2015: 12016: 12020: 12023: 8
2007high 8 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FDF

17,231in 2025

2007: 812008: 682009: 832010: 482011: 772012: 882013: 632014: 602015: 1002016: 1702017: 3702018: 3882019: 4172020: 6872021: 2,4442022: 8,3452023: 11,7482024: 12,1282025: 17,231
2007high 17,231 (2025) · low 48 (2010)2025

MAUDE reports naming product code FDF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007470081
20082—068
2009691083
20104101048
20112—077
20127241088
20132—063
20146164060
20152—1100
20167981170
20174360370
201871010388
20194560417
202042501687
202133002,444
2022514708,345
20236203811,748
20242—012,128
20254194017,231
202651470—

More from Pentax Precision Instrument Corp.

67 FDA decisions under this applicant name. See the company

  • K041395EG-3630URPentax Precision Instrument Corp. · 2004
  • K041397EG-3830UTPentax Precision Instrument Corp. · 20041 recall
  • K041396FG-36UX Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 20041 recall
  • K031789EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
  • K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003

Recent decisions in FDF

The FDF category page

  • K260503Triton 1 SystemNeptune Medical, Inc. · 2026
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  • K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC · 2026
  • K260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026
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https://510kreport.com/device/K822846 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822846: Pentax FC-38LA & FC-38SA Colonofiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822846

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026