510(k) Report

510(k) · Cleared

Cleared

Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL

K052044510(k) SpecialCleared Aug 16, 200519-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

Acmi Corporation · FGB Ureteroscope And Accessories, Flexible/Rigid

Cleared on Aug 16, 2005 as substantially equivalent to K011849 (Circon Video, 2001) after a 19-day review. Its family tree reaches back 1 generation to 2001. 25 later devices descend from it.

Decided
Aug 16, 2005
Review
19 days
Class
Class II
Product code
FGB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011849 (2001). 25 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2020: 3 descendants cleared2009: 1 descendant cleared2018: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2014: 1 descendant cleared2019: 5 descendants cleared2021: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 2 descendants clearedK011849 · Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series (Mro-733) Ureteros · Circon Video · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 4 descendants8 generations forward: 2 descendants K011849 · Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series (Mro-733) Ureteros · Circon Video · 20010+5
  1. Root · 1 generation backK011849 Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633…Circon Video · 2001
  2. This deviceK052044 Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation · 2005
  3. Descendant · cites it directly · 23 of its ownK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
  4. Descendant · 2 generations on · 22 of its ownK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
  5. Descendant · 3 generations on · 20 of its ownK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
  6. Descendant · 4 generations on · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
  7. Descendant · 4 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 12013: 12014: 12015: 12016: 12017: 12018: 12019: 52020: 32021: 22024: 32025: 12026: 2
2007high 5 (2019) · low 0 (2008)2026

Most influential descendants

Showing 5 of 25 · See all
  • K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007 · cites it directly23descendants
  • K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009 · 2 generations on22descendants
  • K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013 · 3 generations on20descendants
  • K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · 4 generations on19descendants
  • K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011849Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642)…Circon Video2001—
0 (this device)K052044Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation2005—
+1K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.2007—
+2K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.2009—
+3K123151Endosee Model 8000 U-ScopeEndosee Corp2013—
+4K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation2014—
+4K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201010
201310
201410
201510
201610
201710
201810
201950
202030
202120
202430
202510
202620
FIG. 1 — Lineage of K052044, 2001–2026Source: 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 FGB? 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 FGB device

  1. #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 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? (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
*K011849Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes…
Summary page 1
…Ureteroscopes Generic/Common Name: Endoscope and accessories Predicate Device ACMI® MR-Series Ureteroscopes KO011849 Intended Uses The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes (MR-6A) are intended for the examination/operation of the urina…
Circon Video2001—

Also cleared against K011849: 1 other device →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.200723
K200369OES Elite Ureteroscopes and AccessoriesOlympus Winter & Ibe GmbH20200

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 no recall.
  • Of its descendants, K072594 (Gyrus Acmi, Inc., 2007) has gone furthest, with 23 descendants of its own.
  • 1 other device also cites its predicate K011849.

How does its category compare?

All FGB devices

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

FDA decisions per year · FGB

17in 2025

2012: 22013: 12014: 22015: 12017: 22018: 42019: 22020: 22021: 32022: 52023: 82024: 162025: 172026 (partial year): 9
2007high 17 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGB

134in 2025

2018: 191 days median2021: 191 days median2022: 205 days median2023: 183 days median2024: 217 days median2025: 134 days median2026 (partial year): 140 days median
2007high 217 (2024) · low 134 (2025)2026

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

Recalls per year · FGB

15in 2024

2022: 42023: 12024: 152026 (partial year): 1
2007high 15 (2024) · low 0 (2007)2026

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

Adverse event reports per year · FGB

1,307in 2025

2007: 62008: 72009: 42010: 202011: 172012: 112013: 82014: 122015: 162016: 352017: 1422018: 1182019: 2072020: 4022021: 3252022: 4552023: 4582024: 5722025: 1,307
2007high 1,307 (2025) · low 4 (2009)2025

MAUDE reports naming product code FGB, 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
20070—06
20080—07
20090—04
20100—020
20110—017
20122—011
20131—08
20142—012
20151—016
20160—035
20172—0142
201841910118
20192—0207
20202—0402
202131910325
202252054455
202381831458
20241621715572
20251713401,307
202691401—

What is it indicated for?

The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are intended for the

examination/operation of the urinary tract, and using additional accessories, to

perform various diagnostic and therapeutic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K011849

1 other device cites the same predicate.

  • K200369OES Elite Ureteroscopes and AccessoriesOlympus Winter & Ibe GmbH · 2020

More from Acmi Corporation

16 FDA decisions under this applicant name. See the company

  • K061975Plasmaseal Open Forceps, Models 2103PK and 91701PKAcmi Corporation · 2006
  • K060752Acmi Dur-HL Laser SystemsAcmi Corporation · 2006
  • K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
  • K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 20052 recalls
  • K043581Dual Lumen CatheterAcmi Corporation · 20051 recall

Recent decisions in FGB

The FGB category page

  • K260708Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed…Vein 360 · 2026
  • K261447CVAC® Aspiration SystemCalyxo, Inc. · 2026
  • K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd. · 2026
  • K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation · 2026
  • K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K052044 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052044: Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052044

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