510(k) Report

510(k) · Cleared

Cleared

General Purpose Latex Transducer Covers

K970515510(k) TraditionalCleared Jun 20, 1997129-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

CIVCO Medical Instruments Co., Inc. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Jun 20, 1997 as substantially equivalent to K895614 (CIVCO Medical Instruments Co., Inc., 1989) after a 129-day review. Its family tree reaches back 1 generation to 1989. 21 later devices descend from it.

Decided
Jun 20, 1997
Review
129 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K895614 (1989). 21 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1998: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2009: 1 descendant cleared2005: 1 descendant cleared2001: 1 descendant cleared2004: 1 descendant cleared2013: 2 descendants cleared2023: 2 descendants cleared2011: 1 descendant cleared2016: 2 descendants cleared2012: 1 descendant cleared2015: 1 descendant cleared2018: 2 descendants cleared2019: 1 descendant cleared2025: 1 descendant clearedK895614 · Civco Latex Ultrasound Sheaths · CIVCO Medical Instruments Co., Inc. · 19891990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 2 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K895614 · Civco Latex Ultrasound Sheaths · CIVCO Medical Instruments Co., Inc. · 19890+5
  1. Root · 1 generation backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
  2. This deviceK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
  3. Descendant · cites it directly · 16 of its ownK991236 General Purpose Neoflex Transducer Cover, Edocavity Neoflex…CIVCO Medical Instruments Co., Inc. · 1999
  4. Descendant · 2 generations on · 14 of its ownK013721 Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · Recalled
  5. Descendant · 3 generations on · 10 of its ownK041077 Imalux Oct Probe GuideImalux Corporation · 2004
  6. Descendant · 4 generations on · 9 of its ownK112770 Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011
  7. Descendant · 5 generations on · 6 of its ownK120800 Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12001: 12004: 12005: 12009: 12011: 12012: 12013: 22015: 12016: 22017: 12018: 22019: 12021: 12023: 22025: 1
1998high 2 (2013) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all
  • K991236General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip…CIVCO Medical Instruments Co., Inc. · 1999 · cites it directly16descendants
  • K013721Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc. · 2001 · 2 generations on14descendants
  • K041077Imalux Oct Probe GuideImalux Corporation · 2004 · 3 generations on10descendants
  • K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011 · 4 generations on9descendants
  • K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013 · 5 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K895614Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc.1989—
0 (this device)K970515General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc.1997—
+1K991236General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover…CIVCO Medical Instruments Co., Inc.1999—
+2K013721Synthetic Polysioprene Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc.20013
+3K041077Imalux Oct Probe GuideImalux Corporation2004—
+4K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc.2011—
+5K120800Nvision Vle Imaging SystemNinepoint Medical, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200110
200410
200510
200910
201110
201210
201320
201510
201620
201710
201820
201910
202110
202320
202510
FIG. 1 — Lineage of K970515, 1989–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (1)

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
…of Predicate Device(s): The CIVCO Latex Ultrasound Transducer Cover is equivalent to CIVCO’s currently, legally marketed Latex Ultrasound Sheath, 510(k) reference number K895614. ORIGINALS ARE {CODED RED sheet1o0f 3 102 First Street South ¢ Kalona, IA 52.247 USA Phone: 319/656-4447 » Fax: 319/656-4451 E…
CIVCO Medical Instruments Co., Inc.1989—

Also cleared against K895614: 3 other devices →

What descends from it? (21)

See all 21

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K991236General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip…CIVCO Medical Instruments Co., Inc.199916
K163502iSR'obot Biopsy KitBiobot Surgical Pte., Ltd.20172
K981406Cervix Coil Latex SheathPhilips Medical Systems (Cleveland), Inc.19980

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?

  • Its one ancestor has no recall.
  • Of its descendants, K991236 (CIVCO Medical Instruments Co., Inc., 1999) has gone furthest, with 16 descendants of its own.
  • 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?

Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Latex Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

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.

  • K974301CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe CoverClk Intl., Inc. · 1998
  • K970891Drape, Surgical-LatexProtek Medical Products, Inc. · 1997
  • K961029Kiltex Probe CoverKiltex Corp. · 19962 recalls

More from CIVCO Medical Instruments Co., Inc.

30 FDA decisions under this applicant name. See the company

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K231783VitroPROCIVCO Medical Instruments Co., Inc. · 2023
  • K222052VitroPROCIVCO Medical Instruments Co., Inc. · 2022
  • K211270CIV-Clear coverCIVCO Medical Instruments Co., Inc. · 2021
  • K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc. · 2017

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/K970515 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970515: General Purpose Latex Transducer Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970515

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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