510(k) · Cleared
ClearedAcmi M4 Telescopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · FBP Telescope, Rigid, Endoscopic
Cleared on Sep 2, 2003 as substantially equivalent to K890328 (Circon Video, 1990) after an 88-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Sep 2, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- FBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890328 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK890328 Adult ResectoscopeCircon Video · 1990 · Recalled
- This deviceK031758 Acmi M4 TelescopesAcmi Corporation · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890328 | Adult Resectoscope | Circon Video | 1990 | 7 |
| 0 (this device) | K031758 | Acmi M4 Telescopes | Acmi Corporation | 2003 | — |
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 FBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K890328 | Adult ResectoscopeSummary page 1…s in diagnostic and surgical procedures of the urological and gynecological systems. Predicate Devices ACMI Resectoscope System and accessories K890328/B Intended Uses ACMI M 4 Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical pro… | 1990 |
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 K890328.
How does its category compare?
All FBP devicesFBP Telescope, Rigid, Endoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FBP
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · FBP
Too few FBP 510(k)s in any year since 2007 to give a median.
Recalls per year · FBP
No recall names FBP since 2007.
Adverse event reports per year · FBP
2in 2024
MAUDE reports naming product code FBP, 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 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 1 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ACMI M4TMSeries Telescopes are intended for use in patients requiring
endoscopic evaluation or for surgical procedures of the urological or
gynecological systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031758: Acmi M4 Telescopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031758
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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