510(k) Report

510(k) · Cleared

Cleared

Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7

K061324510(k) TraditionalCleared Jun 20, 200640-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rtc Inc.-Memcath Technologies, LLC · FED Endoscopic Access Overtube, Gastroenterology-Urology

Cleared on Jun 20, 2006 as substantially equivalent to K000767 (Memcath Technologies, LLC, 2000) and 6 other predicates after a 40-day review. Its family tree reaches back 6 generations to 1992.

Decided
Jun 20, 2006
Review
40 days
Class
Class II
Product code
FED
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.

Other ancestors, by year cleared 2005: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1996: 2 other ancestors2002: 1 other ancestor1995: 1 other ancestor1993: 2 other ancestors1992: 2 other ancestors1985: 1 other ancestor1994: 1 other ancestorK921244 · Disposable Protective Sheath · Vision-Sciences, Inc. · 1992K961591 · Disposable Endosheath for E-F100 Flexible Nasopharyngoscope · Vision-Sciences, Inc. · 1996K963795 · Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath · Vision-Sciences, Inc. · 1996K021344 · B-F200 Bronchoscope with BSS-F21 Endosheath System · Vision-Sciences, Inc. · 2002K031786 · Tne-2000 Esophagoscope with Ecs-D Endosheath System · Vision-Sciences, Inc. · 2003K040215 · Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System · Vision-Sciences, Inc. · 200419851990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 8 other ancestors3 generations back: 1 other ancestor K040215 · Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System · Vision-Sciences, Inc. · 2004K031786 · Tne-2000 Esophagoscope with Ecs-D Endosheath System · Vision-Sciences, Inc. · 2003K021344 · B-F200 Bronchoscope with BSS-F21 Endosheath System · Vision-Sciences, Inc. · 2002K963795 · Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath · Vision-Sciences, Inc. · 1996K961591 · Disposable Endosheath for E-F100 Flexible Nasopharyngoscope · Vision-Sciences, Inc. · 1996K921244 · Disposable Protective Sheath · Vision-Sciences, Inc. · 1992−50
  1. Root · 6 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
  2. 5 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
  3. 4 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
  4. 3 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
  5. 2 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
  6. 1 generation backK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
  7. This deviceK061324 Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K921244Disposable Protective SheathVision-Sciences, Inc.1992—
−5K961591Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc.1996—
−4K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable…Vision-Sciences, Inc.1996—
−3K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc.2002—
−2K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc.2003—
−1K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.2004—
0 (this device)K061324Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199220
199320
199410
199510
199620
199910
200010
200210
200510
FIG. 1 — Lineage of K061324, 1992–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FED? 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 FED device

  1. #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K000767Memcath Urology Introducer Sheath, Model 201
Summary page 1
…TM New Device EndoMedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath Predicate Devices K000767 Memcath Urology Introducer Sheath K042531 UPDATED SLIP Urology Introducer Sheath, Percutaneous Systems,…
Memcath Technologies, LLC2000—
*K042531Updated Slip Urology Introducer Sheath
Summary page 1
…Quik-Cover Flexible Endoscope Barrier Sheath Predicate Devices K000767 Memcath Urology Introducer Sheath K042531 UPDATED SLIP Urology Introducer Sheath, Percutaneous Systems, Inc. K9…
Percutaneous Systems, Incorporated2005—
*K990354Endosheath
Summary page 1
…r Sheath K042531 UPDATED SLIP Urology Introducer Sheath, Percutaneous Systems, Inc. K990354 Vision-Sciences EndoSheaths for use with Flexible ENT Scopes K021344 Vision-Sciences Flexible Fiberopti…
Vision-Sciences, Inc.1999—
*K021344B-F200 Bronchoscope with BSS-F21 Endosheath System
Summary page 1
…Systems, Inc. K990354 Vision-Sciences EndoSheaths for use with Flexible ENT Scopes K021344 Vision-Sciences Flexible Fiberoptic Bronchoscope and EndoSheath System…
Vision-Sciences, Inc.2002—
*K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System
Summary page 1
…opes K021344 Vision-Sciences Flexible Fiberoptic Bronchoscope and EndoSheath System K040215 Vision-Sciences Flexible Cystoscope with EndoSheath System K031786 Vision-Sciences Trans-Nasal Esophago…
Vision-Sciences, Inc.2004—
*K031786Tne-2000 Esophagoscope with Ecs-D Endosheath System
Summary page 1
…ndoSheath System K040215 Vision-Sciences Flexible Cystoscope with EndoSheath System K031786 Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath System K963344 SS-F32 EndoSheath for use with…
Vision-Sciences, Inc.2003—
*K963344Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope
Summary page 1
…s Flexible Cystoscope with EndoSheath System K031786 Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath System K963344 SS-F32 EndoSheath for use with the Vision-Sciences Model S-FlO0 Sigmoidoscope Contact…
Vision-Sciences, Inc.1996—

Also cleared against K000767: 1 other device →

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 2.2 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 FED devices

FED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FED

11in 2025

2007: 12008: 12009: 42010: 32011: 12012: 42013: 22014: 42015: 22016: 52017: 12018: 42019: 52020: 42021: 32022: 12023: 32024: 62025: 112026 (partial year): 6
2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FED

120in 2025

2009: 90 days median2010: 90 days median2012: 82 days median2014: 123 days median2016: 126 days median2018: 122 days median2019: 94 days median2020: 117 days median2021: 189 days median2023: 138 days median2024: 98 days median2025: 120 days median2026 (partial year): 67 days median
2007high 189 (2021) · low 82 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FED

4in 2024

2007: 12013: 32024: 4, 4 Class I
2007high 4 (2024) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · FED

115in 2025

2007: 142008: 182009: 192010: 192011: 202012: 352013: 252014: 342015: 352016: 292017: 322018: 342019: 302020: 332021: 552022: 362023: 532024: 642025: 115
2007high 115 (2025) · low 14 (2007)2025

MAUDE reports naming product code FED, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—114
20081—018
2009490019
2010390019
20111—020
2012482035
20132—325
20144123034
20152—035
20165126029
20171—032
20184122034
2019594030
20204117033
20213189055
20221—036
20233138053
20246984 (4)64
2025111200115
20266670—

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 structures such as the bladder, urethra, lower gastrointestinal tract, and upper gastrointestinal structures including the esophagus.

Indications for use as stated in the FDA summary.

Also cleared against K000767

1 other device cites the same predicate.

  • K061663Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for Otolaryngoscopes and BronchoscopesRtc Inc.-Memcath Technologies, LLC · 2006

More from Rtc Inc.-Memcath Technologies, LLC

2 FDA decisions under this applicant name. See the company

  • K061663Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for Otolaryngoscopes and BronchoscopesRtc Inc.-Memcath Technologies, LLC · 2006

Recent decisions in FED

The FED category page

  • K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026
  • K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2026
  • K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
  • K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026
  • K260965CVAC Aspiration SystemCalyxo, Inc. · 2026

https://510kreport.com/device/K061324 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061324: Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061324

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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