510(k) Report

510(k) · Cleared

Cleared

Ultrasound Transducer Drape

K970889510(k) TraditionalCleared Oct 20, 1997223-day reviewClass II21 CFR 878.4370

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

Protek Medical Products, Inc. · KKX Drape, Surgical, Antimicrobial

Cleared on Oct 20, 1997 as substantially equivalent to K844472 (CIVCO Medical Instruments Co., Inc., 1985) after a 223-day review. Its family tree reaches back 1 generation to 1985. 13 later devices descend from it.

Decided
Oct 20, 1997
Review
223 days
Class
Class II
Product code
KKX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K844472 (1985). 13 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2012: 1 descendant cleared2017: 1 descendant cleared2015: 2 descendants cleared2025: 3 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant clearedK844472 · Civco Scan Drape · CIVCO Medical Instruments Co., Inc. · 19851990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants K844472 · Civco Scan Drape · CIVCO Medical Instruments Co., Inc. · 19850+5
  1. Root · 1 generation backK844472 Civco Scan DrapeCIVCO Medical Instruments Co., Inc. · 1985
  2. This deviceK970889 Ultrasound Transducer DrapeProtek Medical Products, Inc. · 1997
  3. Descendant · cites it directly · 12 of its ownK042445 Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc. · 2004
  4. Descendant · 2 generations on · 8 of its ownK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
  5. Descendant · 3 generations on · 6 of its ownK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
  7. Descendant · 5 generations on · 2 of its ownK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2004: 12012: 12015: 22017: 12018: 12021: 12023: 12024: 12025: 32026: 1
2004high 3 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 13 · See all
  • K042445Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc. · 2004 · cites it directly12descendants
  • K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012 · 2 generations on8descendants
  • K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2015 · 3 generations on6descendants
  • K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018 · 4 generations on4descendants
  • K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K844472Civco Scan DrapeCIVCO Medical Instruments Co., Inc.1985—
0 (this device)K970889Ultrasound Transducer DrapeProtek Medical Products, Inc.1997—
+1K042445Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc.2004—
+2K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.2012—
+3K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT…C.R. Bard, Inc.20151
+4K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT…C. R. Bard2018—
+5K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201210
201520
201710
201810
202110
202310
202410
202530
202610
FIG. 1 — Lineage of K970889, 1985–2026Source: 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 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. #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
  2. #2 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
*K844472Civco Scan Drape
Summary page 2
…parison: The following is a cross reference of products that will be identical: New Device Predicate Device PROTEK Medical Inc Civen Civeo’s 510(k) 1-519-0122 610-013 K844472 1-519-0124 610-015 K844472 1-519-0126 610-209 K844472 *Other part numbers vary only on size and shape These new products have t…
CIVCO Medical Instruments Co., Inc.1985—

Also cleared against K844472: 2 other devices →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042445Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc.200412

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, K042445 (Bard Access Systems, Inc., 2004) has gone furthest, with 12 descendants of its own.
  • 2 other devices also cite its predicate K844472.

How does its category compare?

All KKX devices

KKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KKX

2in 2023

2007: 42008: 52009: 52010: 82011: 42012: 22013: 32014: 62015: 22017: 12020: 12021: 12023: 2
2007high 8 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KKX

182in 2014

2007: 181 days median2008: 164 days median2009: 114 days median2010: 107 days median2011: 147 days median2013: 227 days median2014: 182 days median
2007high 227 (2013) · low 107 (2010)2026

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

Recalls per year · KKX

2in 2024

2007: 12010: 12011: 12012: 12013: 72014: 7, 7 Class I2016: 42024: 22026 (partial year): 2
2007high 7 (2013) · low 0 (2008)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KKX

24in 2025

2007: 242008: 242009: 272010: 252011: 572012: 402013: 632014: 282015: 332016: 562017: 302018: 322019: 412020: 162021: 412022: 192023: 322024: 192025: 24
2007high 63 (2013) · low 16 (2020)2025

MAUDE reports naming product code KKX, 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
20074181124
20085164024
20095114027
20108107125
20114147157
20122—140
20133227763
201461827 (7)28
20152—033
20160—456
20171—030
20180—032
20190—041
20201—016
20211—041
20220—019
20232—032
20240—219
20250—024
20260—2—

What is it indicated for?

Drapes on Ultrasound Transducers used as protective

coverings to isolate a site of surgical incisions from microbial and other

contaminations.

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 K844472

2 other devices cite the same predicate.

  • K970891Drape, Surgical-LatexProtek Medical Products, Inc. · 1997
  • K970513General Purpose Tranducer CoverCIVCO Medical Instruments Co., Inc. · 1997

More from Protek Medical Products, Inc.

9 FDA decisions under this applicant name. See the company

  • K973958General Purpose Atl Needle Guide KitProtek Medical Products, Inc. · 1998
  • K973622Transducer PositionerProtek Medical Products, Inc. · 1997
  • K970893Ultrasound Transducer DrapeProtek Medical Products, Inc. · 1997
  • K973362Needle Guide/GridProtek Medical Products, Inc. · 1997
  • K970885Ultrasound Systems DrapeProtek Medical Products, Inc. · 1997

Recent decisions in KKX

The KKX category page

  • K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical, Ltd. · 2023
  • K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company · 2023
  • K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba · 2021
  • K200238ControlRad Sterile CoverControlrad, Inc. · 2020
  • K163556MediClear PreOpCovalontechnologies, Inc. · 2017

https://510kreport.com/device/K970889 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970889: Ultrasound Transducer Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970889

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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