# K961757: Ecogel 100 Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Eco-Med Pharmaceuticals, Inc.
- Decided: Jul 25, 1996 after 80 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K101952: Konix Ultrasound Gel (2011), 16 descendants of its own
- K112827: Sheathes Ultrasond Gel (2012), 8 descendants of its own
- K151070: Sonishield 100 Antimicrobial Ultrasound Gel (2016), 5 descendants of its own
- K130041: Sheathes Sterile Ultrasound Gel (2013), 5 descendants of its own
- K181363: EcoVue Sterile and Non-Sterile Ultrasound Gels (2018), 4 descendants of its own

## Recalls of this device
- Aug 12, 2021 · Class I · Z-2480-2021: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- Aug 11, 2021 · Class I · Z-0090-2022: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this

Source page: https://510kreport.com/device/K961757
Methodology: https://510kreport.com/methodology