510(k) Report

510(k) · Cleared

Cleared

Civco Scan Drape

K844472510(k) TraditionalCleared Jan 23, 198565-day reviewClass II21 CFR 892.1560

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. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jan 23, 1985 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 85 later devices descend from it.

Decided
Jan 23, 1985
Review
65 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

85 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 3 descendants cleared2000: 1 descendant cleared2013: 2 descendants cleared2009: 2 descendants cleared1998: 1 descendant cleared2023: 5 descendants cleared2004: 1 descendant cleared2012: 2 descendants cleared2017: 5 descendants cleared2014: 3 descendants cleared2011: 1 descendant cleared2015: 4 descendants cleared2024: 6 descendants cleared2025: 8 descendants cleared2020: 8 descendants cleared2019: 6 descendants cleared2016: 1 descendant cleared2018: 8 descendants cleared2021: 6 descendants cleared2026: 6 descendants cleared2022: 6 descendants cleared1990200020102020
  1. This deviceK844472 Civco Scan DrapeCIVCO Medical Instruments Co., Inc. · 1985
  2. Descendant · cites it directly · 69 of its ownK970513 General Purpose Tranducer CoverCIVCO Medical Instruments Co., Inc. · 1997
  3. Descendant · 2 generations on · 61 of its ownK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
  4. Descendant · 3 generations on · 39 of its ownK141459 Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014
  5. Descendant · 4 generations on · 34 of its ownK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
  6. Descendant · 5 generations on · 23 of its ownK161843 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation · 2016 · Recalled

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

1997: 31998: 12000: 12004: 12009: 22011: 12012: 22013: 22014: 32015: 42016: 12017: 52018: 82019: 62020: 82021: 62022: 62023: 52024: 62025: 82026: 6
1997high 8 (2018) · low 0 (1999)2026

Most influential descendants

Showing 5 of 85 · See all
  • K970513General Purpose Tranducer CoverCIVCO Medical Instruments Co., Inc. · 1997 · cites it directly69descendants
  • K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco · 2009 · 2 generations on61descendants
  • K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014 · 3 generations on39descendants
  • K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · 4 generations on34descendants
  • K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation · 2016 · 5 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K844472Civco Scan DrapeCIVCO Medical Instruments Co., Inc.1985—
+1K970513General Purpose Tranducer CoverCIVCO Medical Instruments Co., Inc.1997—
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax…Civco200917
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation2014—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20152
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation20161

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199730
199810
200010
200410
200920
201110
201220
201320
201430
201540
201610
201750
201880
201960
202080
202160
202260
202350
202460
202580
202660
FIG. 1 — Lineage of K844472, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYO? 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 IYO device

  1. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (85)

See all 85

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

NumberDeviceApplicantDecidedDescendants
K970513General Purpose Tranducer CoverCIVCO Medical Instruments Co., Inc.199769
K970889Ultrasound Transducer DrapeProtek Medical Products, Inc.199713
K970891Drape, Surgical-LatexProtek Medical Products, Inc.19970

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?

  • Of its descendants, K970513 (CIVCO Medical Instruments Co., Inc., 1997) has gone furthest, with 69 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

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

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https://510kreport.com/device/K844472 · printed Nov 4, 2026

Cite this page

510(k) Report. “K844472: Civco Scan Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844472

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026