510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Aquasonic 100 Ultrasound Trans. Gel,

K802146510(k) TraditionalCleared Oct 10, 198035-day reviewClass II21 CFR 892.1560Recalls 1

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

Parker Laboratories, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Oct 10, 1980 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it. It has been recalled once.

Decided
Oct 10, 1980
Review
35 days
Class
Class II
Product code
IYO
Recalls
1
Predicates
0

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

Descendants, by year cleared 2012: 2 descendants cleared2003: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2015: 2 descendants cleared2026: 1 descendant cleared2025: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared19801990200020102020
  1. This deviceK802146 Aquasonic 100 Ultrasound Trans. Gel,Parker Laboratories, Inc. · 1980
  2. Descendant · cites it directly · 10 of its ownK072515 Embrace GelOrison Corporation · 2007
  3. Descendant · 2 generations on · 8 of its ownK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
  4. 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
  5. Descendant · 4 generations on · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
  6. 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 15 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12011: 12012: 22013: 12015: 22018: 12021: 12023: 12024: 12025: 22026: 1
2003high 2 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 15 · See all
  • K072515Embrace GelOrison Corporation · 2007 · cites it directly10descendants
  • 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
0 (this device)K802146Aquasonic 100 Ultrasound Trans. Gel,Parker Laboratories, Inc.1980—
+1K072515Embrace GelOrison Corporation2007—
+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
200310
200710
201110
201220
201310
201520
201810
202110
202310
202410
202520
202610
FIG. 1 — Lineage of K802146, 1980–2026Source: 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? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K072515Embrace GelOrison Corporation200710
K121311Thixo-Gel Ultrasound SprayCloverline International Pharma Services GmbH20122
K030889Ultraekogel Models EK 2000 & EK 2001Inmed Ltda.20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 13, 2017Class IIZ-1777-2018Process controlThere is a potential for the gel packets to have leaks in the packet seal.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K072515 (Orison Corporation, 2007) has gone furthest, with 10 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—

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https://510kreport.com/device/K802146 · printed Nov 3, 2026

Cite this page

510(k) Report. “K802146: Aquasonic 100 Ultrasound Trans. Gel,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K802146

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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