510(k) Report

510(k) · Cleared

Cleared

Liqua-Sonic Gel

K841871510(k) TraditionalCleared Mar 14, 1985311-day reviewClass II21 CFR 882.1275

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

Chester Labs, Inc. · GYB Media, Electroconductive

Cleared on Mar 14, 1985 after a 311-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 14, 1985
Review
311 days
Class
Class II
Product code
GYB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared1990200020102020
  1. This deviceK841871 Liqua-Sonic GelChester Labs, Inc. · 1985
  2. Descendant · cites it directly · 0 of its ownK102637 Dynarex Ultrasound GelDynarex Corporation · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K102637Dynarex Ultrasound GelDynarex Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K841871Liqua-Sonic GelChester Labs, Inc.1985—
+1K102637Dynarex Ultrasound GelDynarex Corporation2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K841871, 1985–2011Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GYB? 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 GYB device

  1. #1 K243749 Jmoon Conductive Gelscore 10.9 · 7 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?

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

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K102637Dynarex Ultrasound GelDynarex Corporation20110

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, K102637 (Dynarex Corporation, 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GYB devices

GYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GYB

1in 2025

2012: 12016: 12017: 12019: 12020: 32021: 22022: 32023: 12025: 1
2007high 3 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GYB

101in 2022

2020: 198 days median2022: 101 days median
2007high 198 (2020) · low 101 (2022)2026

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

Recalls per year · GYB

1in 2021

2021: 1, 1 Class I
2007high 1 (2021) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GYB

2in 2025

2007: 92008: 42009: 32010: 72011: 102012: 152013: 22014: 52015: 32016: 32017: 42018: 22019: 32020: 22021: 42022: 42023: 62024: 42025: 2
2007high 15 (2012) · low 2 (2013)2025

MAUDE reports naming product code GYB, 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
20070—09
20080—04
20090—03
20100—07
20110—010
20121—015
20130—02
20140—05
20150—03
20161—03
20171—04
20180—02
20191—03
2020319802
20212—1 (1)4
2022310104
20231—06
20240—04
20251—02
20260—0—
Cite this page

510(k) Report. “K841871: Liqua-Sonic Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K841871

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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