# K012816: Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corp.
- Decided: Oct 17, 2002 after 421 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- 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 no predicate by number.

## Most influential descendants
- K063190: Silverseal Wound Packing Strips with X-Static (2007), 0 descendants of its own

## Indications for use
The Dynarex Iodoform Packing Strip is a device used as an anti-bacterial barrier and for general use in wound packing and management. This Iodoform Packing Strip is indicated for external use only. Federal (USA) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K012816
Methodology: https://510kreport.com/methodology