# K130553: Absoclear

- Pathway: 510(k) (Traditional)
- Applicant: Pharmaplast S.A.E.
- Decided: Jul 3, 2013 after 121 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
Longest line of descent: 1 generation back to K973036 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres, 3M Healthcare (1997). Our reading of the summary gave K973063, FDA’s number for Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for… (Aspect Vision Care, Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “3M Tegaderm Transparent Film Dressing”. Summary page 2.

## Indications for use
Sterile, single-use dressings for management of pressure ulcers, 1s and 2 nd degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.

Source page: https://510kreport.com/device/K130553
Methodology: https://510kreport.com/methodology