510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Pentax Cystofiberscope, Model Fcy-15P

K914008510(k) TraditionalCleared Jan 10, 1992123-day reviewClass II21 CFR 876.1500Recalls 1

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. · FAJ Cystoscope And Accessories, Flexible/Rigid

Cleared on Jan 10, 1992 after a 123-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 27 later devices descend from it. It has been recalled once.

Decided
Jan 10, 1992
Review
123 days
Class
Class II
Product code
FAJ
Recalls
1
Predicates
0

27 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 3 descendants cleared2007: 2 descendants cleared2026: 1 descendant cleared2018: 2 descendants cleared2016: 1 descendant cleared2020: 1 descendant cleared2019: 2 descendants cleared2023: 3 descendants cleared2024: 4 descendants cleared2025: 2 descendants cleared2022: 4 descendants cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK914008 Pentax Cystofiberscope, Model Fcy-15PPentax Precision Instrument Corp. · 1992
  2. Descendant · cites it directly · 26 of its ownK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
  3. Descendant · 2 generations on · 23 of its ownK053560 Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006
  4. Descendant · 2 generations on · 20 of its ownK072180 Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
  5. Descendant · 3 generations on · 14 of its ownK160766 Ambu USR, Ambu MAmbu A/S · 2016
  6. Descendant · 4 generations on · 13 of its ownK193095 Ambu aScope 4 CystoAmbu A/S · 2020

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2004: 12006: 32007: 22016: 12018: 22019: 22020: 12021: 12022: 42023: 32024: 42025: 22026: 1
2004high 4 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 27 · See all
  • K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc. · 2004 · cites it directly26descendants
  • K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006 · 2 generations on23descendants
  • K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007 · 2 generations on20descendants
  • K160766Ambu USR, Ambu MAmbu A/S · 2016 · 3 generations on14descendants
  • K193095Ambu aScope 4 CystoAmbu A/S · 2020 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914008Pentax Cystofiberscope, Model Fcy-15PPentax Precision Instrument Corp.1992—
+1K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.2004—
+2K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc.2006—
+2K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc.2007—
+3K160766Ambu USR, Ambu MAmbu A/S2016—
+4K193095Ambu aScope 4 CystoAmbu A/S2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200630
200720
201610
201820
201920
202010
202110
202240
202330
202440
202520
202610
FIG. 1 — Lineage of K914008, 1992–2026Source: 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 FAJ? 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 FAJ device

  1. #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (27)

See all 27

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.200426

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 6, 2016Class IIZ-2070-2016Device DesignPentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K040215 (Vision-Sciences, Inc., 2004) has gone furthest, with 26 descendants of its own.

How does its category compare?

All FAJ devices

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

FDA decisions per year · FAJ

8in 2025

2007: 22009: 22010: 12012: 12014: 12016: 12017: 22018: 22019: 32020: 22021: 32022: 52023: 52024: 92025: 82026 (partial year): 5
2007high 9 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAJ

98in 2025

2019: 207 days median2021: 127 days median2022: 170 days median2023: 207 days median2024: 130 days median2025: 98 days median2026 (partial year): 123 days median
2007high 207 (2019) · low 98 (2025)2026

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

Recalls per year · FAJ

7in 2023

2017: 12022: 12023: 7
2007high 7 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FAJ

2,690in 2025

2007: 92008: 102009: 102010: 92011: 132012: 82013: 122014: 62015: 282016: 752017: 792018: 792019: 1022020: 3392021: 4942022: 7442023: 9202024: 8922025: 2,690
2007high 2,690 (2025) · low 6 (2014)2025

MAUDE reports naming product code FAJ, 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
20072—09
20080—010
20092—010
20101—09
20110—013
20121—08
20130—012
20141—06
20150—028
20161—075
20172—179
20182—079
201932070102
20202—0339
202131270494
202251701744
202352077920
202491300892
202589802,690
202651230—

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 FAJ

The FAJ category page

  • K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO)…Olympus Winter & Ibe GmbH · 2026
  • K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456)…Verathon Medical (Canada) Ulc · 2026
  • K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°…Strauss Surgical USA · 2026
  • K253905PrimeSight UltraView SystemCogentix Medical, Inc. · 2026
  • K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc. · 2026

https://510kreport.com/device/K914008 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914008: Pentax Cystofiberscope, Model Fcy-15P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914008

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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