510(k) Report

510(k) · Cleared

Cleared

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)

K244001510(k) TraditionalCleared May 2, 2025127-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

Karl Storz SE & CO. KG · FBO Cystourethroscope

Cleared on May 2, 2025 as substantially equivalent to K945185 (KARL STORZ Endoscopy-America, Inc., 1995) after a 127-day review. Its family tree reaches back 1 generation to 1995.

Decided
May 2, 2025
Review
127 days
Class
Class II
Product code
FBO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K945185 (1995). No later device cites it as a predicate yet.

Reference device: K221690 · Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R), Light Guide Adapter (Maj-1413) · Olympus Medical Systems Corp. · 2022 · recalledK945185 · Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB) · KARL STORZ Endoscopy-America, Inc. · 1995 · recalled1995200020052010201520202025
K945185 · Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB) · KARL STORZ Endoscopy-America, Inc. · 1995 · recalled0
  1. Root · 1 generation backK945185 Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB)KARL STORZ Endoscopy-America, Inc. · 1995 · Recalled
  2. This deviceK244001 KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ…Karl Storz SE & CO. KG · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945185Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB)KARL STORZ Endoscopy-America, Inc.19951
0 (this device)K244001KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ…Karl Storz SE & CO. KG2025—
FIG. 1 — Lineage of K244001, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 FBO? 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 FBO device

  1. #1 K243409 KARL STORZ Pediatric Cysto-Urethro-Fiberscope…score 8.7 · 2 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K945185Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB)
Summary page 5
…oscope and accessories Device Panel: Gastroenterology & Urology Predicate Device: KARL STORZ CYSTOSCOPE ENDOSCOPE,FIBEROPTIC (11277A/AU) – K945185 The K945185 device was subject to a reprocessing-related recall, which was resolved vi…
KARL STORZ Endoscopy-America, Inc.19951
†K221690Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R)…Olympus Medical Systems Corp.20223

Also cleared against K945185: 1 other device →

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?

  • Its one ancestor has a recall.
  • 1 other device also cites its predicate K945185.

How does its category compare?

All FBO devices

FBO Cystourethroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · FBO

1in 2025

2007: 12008: 22014: 12024: 12025: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FBO

Too few FBO 510(k)s in any year since 2007 to give a median.

Recalls per year · FBO

1in 2023

2022: 52023: 1
2007high 5 (2022) · low 0 (2007)2026

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

Adverse event reports per year · FBO

26in 2025

2008: 32009: 22010: 32011: 32012: 72013: 52014: 102015: 102016: 92017: 112018: 112019: 152020: 202021: 182022: 332023: 292024: 302025: 26
2007high 33 (2022) · low 0 (2007)2025

MAUDE reports naming product code FBO, 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
20071—00
20082—03
20090—02
20100—03
20110—03
20120—07
20130—05
20141—010
20150—010
20160—09
20170—011
20180—011
20190—015
20200—020
20210—018
20220—533
20230—129
20241—030
20251—026
20260—0—

What is it indicated for?

The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

Indications for use as stated in the FDA summary.

Also cleared against K945185

1 other device cites the same predicate.

  • K131364Flexible Cmos-Video-Cysto-UrethroscopeKARL STORZ Endoscopy-America, Inc. · 20141 recall

More from Karl Storz SE & CO. KG

33 FDA decisions under this applicant name. See the company

  • K260581KARL STORZ Flexible Video Neuro-EndoscopeKarl Storz SE & CO. KG · 2026
  • K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver…Karl Storz SE & CO. KG · 2026
  • K254303Karl Storz SupraloopKarl Storz SE & CO. KG · 2026
  • K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION…Karl Storz SE & CO. KG · 2026

Recent decisions in FBO

The FBO category page

  • K243409KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)Karl Storz SE & CO. KG · 2024
  • K131364Flexible Cmos-Video-Cysto-UrethroscopeKARL STORZ Endoscopy-America, Inc. · 20141 recall
  • K082046Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/Acui and Circon Aur-735 Pediatric…KARL STORZ Endoscopy-America, Inc. · 20081 recall
  • K080780Anchorage Scope, Model 000003Epitek, Inc. · 2008
  • K062918Karl Storz Flexible Video-Urethro-Cystoscope SystemKARL STORZ Endoscopy-America, Inc. · 20071 recall

https://510kreport.com/device/K244001 · printed Nov 6, 2026

Cite this page

510(k) Report. “K244001: KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244001

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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