510(k) · Cleared
ClearedEndomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for Otolaryngoscopes and Bronchoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rtc Inc.-Memcath Technologies, LLC · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Sep 6, 2006 as substantially equivalent to K000767 (Memcath Technologies, LLC, 2000) and 6 other predicates after a 93-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Sep 6, 2006
- Review
- 93 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K921244 (1992). 19 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 4 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 3 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 2 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 1 generation backK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
- This deviceK061663 Endomedical Technologies Quik-Cover Flexible Endoscope Barrier…Rtc Inc.-Memcath Technologies, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −5 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −4 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −3 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −2 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −1 | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | Vision-Sciences, Inc. | 2004 | — |
| 0 (this device) | K061663 | Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for… | Rtc Inc.-Memcath Technologies, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K000767 | Memcath Urology Introducer Sheath, Model 201Summary page 1…choscope only May 30, 2006 New Device EndoMedical Technologies Quik-Cover TM Flexible Endoscope Barrier Sheath Predicate Devices K000767 Memcath Urology Introducer Sheath K042531 UPDATED SLIP Urology Introducer Sheath, Percutaneous Systems,… | 2000 |
| * | K042531 | Updated Slip Urology Introducer SheathSummary page 1…chnologies Quik-Cover TM Flexible Endoscope Barrier Sheath Predicate Devices K000767 Memcath Urology Introducer Sheath K042531 UPDATED SLIP Urology Introducer Sheath, Percutaneous Systems, Inc. V'K99… | 2005 |
| * | K990354 | EndosheathSummary page 1…cer Sheath K042531 UPDATED SLIP Urology Introducer Sheath, Percutaneous Systems, Inc. V'K990354 Vision-Sciences EndoSheaths fot use with Flexible ENT Scopes 1K021344 Vision-Sciences Flexible Fiberopti… | 1999 |
| * | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath SystemSummary page 1…s Systems, Inc. V'K990354 Vision-Sciences EndoSheaths fot use with Flexible ENT Scopes 1K021344 Vision-Sciences Flexible Fiberoptic Bronchoscope and EndoSheath System… | 2002 |
| * | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemSummary page 1…copes 1K021344 Vision-Sciences Flexible Fiberoptic Bronchoscope and EndoSheath System K040215 Vision-Sciences Flexible Cystoscope with EndoSheath System 1 1K031786 Vision-Sciences Trans-Nasal Esophago… | 2004 |
| * | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath SystemSummary page 1…EndoSheath System K040215 Vision-Sciences Flexible Cystoscope with EndoSheath System 1 1K031786 Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath System K963344 SS-F32 EndoSheath for use with… | 2003 |
| * | K963344 | Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic SigmoidoscopeSummary page 1…es Flexible Cystoscope with EndoSheath System 1 1K031786 Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath System K963344 SS-F32 EndoSheath for use with the Vision-Sciences Model S-Fl100 Sigmoidoscope Contact… | 1996 |
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 14 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K000767.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
The EndoMedical Technologies Quik-Cover flexible endoscope barrier sheath provides a sterile, disposable protective covering for endoscopes used during examination of the upper airway, vocal chords, nasal passages, esophagus and pulmonary structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061663 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061663: Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for Otolaryngoscopes and Bronchoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061663
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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