510(k) · Cleared
ClearedOmnitech Resectoscope Cutting Loop Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnitech Systems, Inc. · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Cleared on Jul 10, 1998 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Jul 10, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- KNF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK981464 Omnitech Resectoscope Cutting Loop ElectrodeOmnitech Systems, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK070315 Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK122605 PKS BillGyrus Acmi, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK254303 Karl Storz SupraloopKarl Storz SE & CO. KG · 2026
- Descendant · 3 generations on · 0 of its ownK142525 PK Lap LoopOlympus Winter & Ibe GmbH · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K070315Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007 · cites it directly7descendants
- K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011 · 2 generations on3descendants
- K122605PKS BillGyrus Acmi, Inc. · 2012 · 3 generations on1descendant
- K254303Karl Storz SupraloopKarl Storz SE & CO. KG · 2026 · 2 generations on0descendants
- K142525PK Lap LoopOlympus Winter & Ibe GmbH · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981464 | Omnitech Resectoscope Cutting Loop Electrode | Omnitech Systems, Inc. | 1998 | — |
| +1 | K070315 | Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | 2007 | 3 |
| +2 | K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) | Gyrus Acmi, Inc. | 2011 | — |
| +3 | K122605 | PKS Bill | Gyrus Acmi, Inc. | 2012 | — |
| +2 | K254303 | Karl Storz Supraloop | Karl Storz SE & CO. KG | 2026 | — |
| +3 | K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNF? 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 KNF device
- #1 K240503 Sonata Transcervical Fibroid Ablation System 2.2score 13.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070315 | Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | 2007 | 7 |
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?
- Of its descendants, K070315 (Lina Medical Aps, 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KNF devicesKNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNF
Too few KNF 510(k)s in any year since 2007 to give a median.
Recalls per year · KNF
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNF
93in 2025
MAUDE reports naming product code KNF, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 3 | 1 |
| 2010 | 1 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 93 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Omnitech Resectoscope Cutting Loop Electrode Device is indicated for resection/coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981464: Omnitech Resectoscope Cutting Loop Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981464
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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