510(k) Report

510(k) · Cleared

Cleared

CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe Cover

K974301510(k) TraditionalCleared Feb 6, 199881-day reviewClass II21 CFR 892.1570

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

Clk Intl., Inc. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Feb 6, 1998 as substantially equivalent to K895614 (CIVCO Medical Instruments Co., Inc., 1989) and 5 other predicates after an 81-day review. Its family tree reaches back 2 generations to 1989.

Decided
Feb 6, 1998
Review
81 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K895614 (1989). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1995: 1 other ancestor1992: 1 other ancestor1990: 1 other ancestorK895614 · Civco Latex Ultrasound Sheaths · CIVCO Medical Instruments Co., Inc. · 1989K961029 · Kiltex Probe Cover · Kiltex Corp. · 1996 · recalled1985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors K961029 · Kiltex Probe Cover · Kiltex Corp. · 1996 · recalledK895614 · Civco Latex Ultrasound Sheaths · CIVCO Medical Instruments Co., Inc. · 19890
  1. Root · 2 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
  2. 1 generation backK961029 Kiltex Probe CoverKiltex Corp. · 1996 · Recalled
  3. This deviceK974301 CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe CoverClk Intl., Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K895614Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc.1989—
−1K961029Kiltex Probe CoverKiltex Corp.19962
0 (this device)K974301CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe CoverClk Intl., Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199510
199610
FIG. 1 — Lineage of K974301, 1989–1998Source: 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 ITX? 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 ITX device

  1. #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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? (6)

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
*K895614Civco Latex Ultrasound Sheaths
Summary page 1
…he 510(k) process. The CLK Latex Ultrasound Cover is substantially equivalent to (for example) the following devices: 1. Civco Latex Ultrasound Sheaths, cleared under K-895614, by Civco Medical Instruments, 2. Civco Probe Cover, cleared under K-943393 by Civco Medical Instruments, 3. Kiltex Probe Covers…
CIVCO Medical Instruments Co., Inc.1989—
*K943393Civco Probe Boot/Cord Cover
Summary page 1
…t to (for example) the following devices: 1. Civco Latex Ultrasound Sheaths, cleared under K-895614, by Civco Medical Instruments, 2. Civco Probe Cover, cleared under K-943393 by Civco Medical Instruments, 3. Kiltex Probe Covers, cleared under K-961029, by Kiltex Corporation, and 4. Eclipse Probe Cover…
CIVCO Medical Instruments Co., Inc.1995—
*K961029Kiltex Probe Cover
Summary page 1
…cleared under K-895614, by Civco Medical Instruments, 2. Civco Probe Cover, cleared under K-943393 by Civco Medical Instruments, 3. Kiltex Probe Covers, cleared under K-961029, by Kiltex Corporation, and 4. Eclipse Probe Cover, cleared under K-953673, by Parker Laboratories. 5. Corometrics Sanitary lat…
Kiltex Corp.19962
*K953673Eclipse Probe Cover
Summary page 1
…cleared under K-943393 by Civco Medical Instruments, 3. Kiltex Probe Covers, cleared under K-961029, by Kiltex Corporation, and 4. Eclipse Probe Cover, cleared under K-953673, by Parker Laboratories. 5. Corometrics Sanitary latex Probe cover, cleared under K-900805 and/or K-920374 by Corometrics Medica…
Parker Laboratories, Inc.19961
*K900805Aloka 500 Diagnostic Ultrasound Scanning System
Summary page 1
…K-961029, by Kiltex Corporation, and 4. Eclipse Probe Cover, cleared under K-953673, by Parker Laboratories. 5. Corometrics Sanitary latex Probe cover, cleared under K-900805 and/or K-920374 by Corometrics Medical Systems. Characteristics of the CLK™ Latex Probe Covers are compared with those of other…
Ge Medical Systems Information Technologies1990—
*K920374Aloka 650CL Diagnostic Ultrasound System
Summary page 1
…tex Corporation, and 4. Eclipse Probe Cover, cleared under K-953673, by Parker Laboratories. 5. Corometrics Sanitary latex Probe cover, cleared under K-900805 and/or K-920374 by Corometrics Medical Systems. Characteristics of the CLK™ Latex Probe Covers are compared with those of other products current…
Ge Medical Systems Information Technologies1992—

Also cleared against K895614: 3 other devices →

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 9 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K895614.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITX

4in 2025

2007: 102008: 122009: 172010: 102011: 102012: 72013: 32014: 42015: 12016: 42017: 62018: 22019: 12020: 32021: 32022: 22023: 62024: 32025: 42026 (partial year): 6
2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007: 26 days median2008: 73 days median2009: 28 days median2010: 42 days median2011: 16 days median2012: 25 days median2013: 105 days median2014: 41 days median2016: 151 days median2017: 110 days median2020: 120 days median2021: 139 days median2023: 213 days median2024: 81 days median2025: 126 days median2026 (partial year): 158 days median
2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2008: 42009: 42010: 42011: 12012: 12014: 12015: 52017: 12018: 152020: 32021: 10, 10 Class I2022: 62023: 12024: 12025: 2
2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007: 162008: 392009: 232010: 302011: 342012: 292013: 382014: 432015: 1832016: 2692017: 4122018: 1302019: 1192020: 1162021: 1462022: 872023: 1382024: 9882025: 571
2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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
20071026016
20081273439
20091728423
20101042430
20111016134
2012725129
20133105038
2014441143
20151—5183
201641510269
201761101412
20182—15130
20191—0119
202031203116
2021313910 (10)146
20222—687
202362131138
20243811988
202541262571
202661580—

What is it indicated for?

Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K895614

3 other devices cite the same predicate.

  • K970891Drape, Surgical-LatexProtek Medical Products, Inc. · 1997
  • K970515General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
  • K961029Kiltex Probe CoverKiltex Corp. · 19962 recalls

More from Clk Intl., Inc.

2 FDA decisions under this applicant name. See the company

  • K974371CLK Int'l Powder Free Latex Examination GloveClk Intl., Inc. · 1998

Recent decisions in ITX

The ITX category page

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K261170BA-004CCFujifilm Corporation · 2026
  • K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
  • K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
  • K262474ND Needle Guidance SystemAccurate Access, LLC · 2026

https://510kreport.com/device/K974301 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974301: CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974301

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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