AQUASONIC 100 ULTRASOUND TRANS. GEL,— 510(k) K802146

Name: FDA 510(k) clearance K802146
Creator: U.S. Food and Drug Administration
Published: 1980-10-10

Substantially Equivalent

Parker Laboratories, Inc.

FDA 510(k) clearance K802146 for AQUASONIC 100 ULTRASOUND TRANS. GEL,, Substantially Equivalent on 1980-10-10. Applicant: Parker Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Parker Laboratories, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1980-09-05
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

More clearances from Parker Laboratories, Inc.

view all

K233965 — UltraDrape UGPIV Barrier and Securement (34-15)2024-08-15
K953673 — ECLIPSE PROBE COVER1996-03-14
K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS1995-02-23
K864556 — AQUALUBE(TM)1986-12-01
K861239 — ACRYLIC SOLDER1986-04-17

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K802146

K-number listed on FDA's recall record

Z-1777-2018 — Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/caseClass II·Terminated·Parker Laboratories, Inc.·20170413

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K802146.

Data sourced from openFDA. This site is unofficial and independent of the FDA.