510(k) · Cleared
ClearedModification to: Roei Working Element and Roei Cutting Loops
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roei Medical Technologies, Ltd. · FAS Electrode, Electrosurgical, Active, Urological
Cleared on Jan 6, 2006 as substantially equivalent to K050910 (Roei Medical Technologies, Ltd., 2005) after a 37-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Jan 6, 2006
- Review
- 37 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903323 (1990). 14 ancestors in all, the oldest K790071 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK903323 Resectoscope LoopsOlympus Corp. · 1990
- 3 generations backK971512 Ams Coaguloop Resection ElectrodeAmerican Medical Systems, Inc. · 1997
- 2 generations backK991314 CoaguloopAmerican Medical Systems, Inc. · 1999
- 1 generation backK050910 Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005
- This deviceK053322 Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903323 | Resectoscope Loops | Olympus Corp. | 1990 | — |
| −3 | K971512 | Ams Coaguloop Resection Electrode | American Medical Systems, Inc. | 1997 | — |
| −2 | K991314 | Coaguloop | American Medical Systems, Inc. | 1999 | — |
| −1 | K050910 | Roei Working Element and Roel Cutting Loops | Roei Medical Technologies, Ltd. | 2005 | — |
| 0 (this device) | K053322 | Modification to: Roei Working Element and Roei Cutting Loops | Roei Medical Technologies, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
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 FAS? 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 FAS device
- #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K050910 | Roei Working Element and Roel Cutting LoopsSummary page 1…, Working Element. Endoscope and Accessories. Endoseopic electrosurgical unit and accessories. Predicate Devices Roei Working Elements and Roei Cutting Loops (K050910) 07 Intended Use The Roei Working Element and Roei Cuttin… | 2005 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 4 of the 14 ancestors have a recall of any class.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 2025
MAUDE reports naming product code FAS, 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 | 6 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 3 | 150 | 0 | 25 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 2 | 69 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 61 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 2 | — | 4 | 102 |
| 2022 | 1 | — | 0 | 147 |
| 2023 | 0 | — | 1 | 329 |
| 2024 | 1 | — | 0 | 310 |
| 2025 | 2 | — | 0 | 395 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Roei Working Element and Roei Cutting Loops are device accessories intended for use with monopolar resectoscope systems for the resection of soft tissue and are indicated for use in transuretheral bladder tumor resection (TURBT), transurethral prostatic and bladder biopsy, and transurethral resection of the prostate (TURP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053322 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053322: Modification to: Roei Working Element and Roei Cutting Loops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053322
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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