510(k) · Cleared
ClearedImalux Oct Probe Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imalux Corporation · KKX Drape, Surgical, Antimicrobial
Cleared on Jun 25, 2004 as substantially equivalent to K013721 (CIVCO Medical Instruments Co., Inc., 2001) and 1 other predicate after a 60-day review. Its family tree reaches back 4 generations to 1989. 10 later devices descend from it.
- Decided
- Jun 25, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K895614 (1989). 10 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 3 generations backK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- 2 generations backK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
- 1 generation backK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · Recalled
- This deviceK041077 Imalux Oct Probe GuideImalux Corporation · 2004
- Descendant · cites it directly · 9 of its ownK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 2 of its ownK153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon…Ninepoint Medical, Inc. · 2016
- Descendant · 5 generations on · 1 of its ownK182616 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE…Ninepoint Medical, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011 · cites it directly9descendants
- K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013 · 2 generations on6descendants
- K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. · 2015 · 3 generations on5descendants
- K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc. · 2016 · 4 generations on2descendants
- K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc. · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| −3 | K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| −2 | K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover… | CIVCO Medical Instruments Co., Inc. | 1999 | — |
| −1 | K013721 | Synthetic Polysioprene Ultrasound Transducer Cover | CIVCO Medical Instruments Co., Inc. | 2001 | 3 |
| 0 (this device) | K041077 | Imalux Oct Probe Guide | Imalux Corporation | 2004 | — |
| +1 | K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | Ninepoint Medical, Inc. | 2011 | — |
| +2 | K120800 | Nvision Vle Imaging System | Ninepoint Medical, Inc. | 2013 | — |
| +3 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation… | Ninepoint Medical, Inc. | 2015 | 1 |
| +4 | K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE… | Ninepoint Medical, Inc. | 2016 | — |
| +5 | K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 KKX? 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 KKX device
- #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K013721 | Synthetic Polysioprene Ultrasound Transducer CoverSummary page 1…Device Name 510(k) Number CIVCO Medical Instruments Synthetic Polyisoprene K013721 Ultrasound Transducer Cover Vision-Sciences Slide-OnTM EndoSheath® System for K990354… | 2001 |
| * | K990354 | EndosheathSummary page 1…s Synthetic Polyisoprene K013721 Ultrasound Transducer Cover Vision-Sciences Slide-OnTM EndoSheath® System for K990354 use with Flexible ENT Scopes Page I June 22,… | 1999 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112770 | Nvision Vle Imaging System, Nvision Vle Catheter | 2011 | 9 |
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 15 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K112770 (Ninepoint Medical, Inc., 2011) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K013721.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KKX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KKX
182in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKX
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KKX
24in 2025
MAUDE reports naming product code KKX, 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 | 4 | 181 | 1 | 24 |
| 2008 | 5 | 164 | 0 | 24 |
| 2009 | 5 | 114 | 0 | 27 |
| 2010 | 8 | 107 | 1 | 25 |
| 2011 | 4 | 147 | 1 | 57 |
| 2012 | 2 | — | 1 | 40 |
| 2013 | 3 | 227 | 7 | 63 |
| 2014 | 6 | 182 | 7 (7) | 28 |
| 2015 | 2 | — | 0 | 33 |
| 2016 | 0 | — | 4 | 56 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 2 | — | 0 | 32 |
| 2024 | 0 | — | 2 | 19 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Imalux OCT (Optical Coherence Tomography) Probe Sheath is a sterile, single-use, protective sheath that is used as an accessory with the Imalux OCT Imaging System. The Imalux OCT Probe Sheath is intended to serve as a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the probe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041077: Imalux Oct Probe Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041077
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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