# K964016: Tielle Hydropolymer Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Dec 31, 1996 after 85 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Allevyn Hydrophilic Polyurethane Dressing: named in the summary without a submission number

## Most influential descendants
- K972915: Erbium 2000 Laser Family (1997), 0 descendants of its own

## Indications for use
TIELLE Dressing is indicated for the management of both chronic and superficial, moderate to heavily exudating wounds, including the following: Pressure sores (all stages) Venous ulcers Skin tears Second degree burns Donor and graft sites Acute wounds healing by secondary or primary intention Surgically debrided wounds

Source page: https://510kreport.com/device/K964016
Methodology: https://510kreport.com/methodology