# K053476: Allwound

- Pathway: 510(k) (Traditional)
- Applicant: At Squared, LLC
- Decided: Jun 26, 2006 after 194 days
- Product code: SEJ (Wound Dressings Containing Topical Analgesics)
- 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: 2 generations back to K935060 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022584: Cardiotech Antibotic Hydrogel Wound Dressing, Cardiotech Intl. (2002) Summary page 1.
- K990530: Kerlix MD Antimicrobial Gauze Dressing, The Kendall Company, L.P. (2000) Summary page 1.
- K972185: 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride, Steripak, Ltd. (1998). Our reading of the summary gave K972195, FDA’s number for Powder-Free Nitrile Examination Glove, Blue or White… (Absolute Synthetic Technologies Malaysia Sdn. Bhd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “20mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride”.

## Cited in the summary but kept off the family tree
- K020505: Synthes Translating Maxillary Distractor, Synthes (Usa) (2002). Our reading of the summary gave K020505, FDA’s number for Synthes Translating Maxillary Distractor (Synthes (Usa)). Its FDA name has none of the distinctive words the summary uses for the device it names, “Regenecare Wound Gel”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K211943: Microlyte Ag/Lidocaine (2024), 0 descendants of its own

## Indications for use
WoundPal is indicated for use as a primary dressing in the management of partial and full-thickness wounds, including diabetic ulcers, venous stasis ulcers, pressure ulcers, surgical wounds, ischemic ulcers, traumatic wounds, superficial burns, donor sites, and abrasions and lacerations. Absorbs wound exudates and maintains a moist environment.

Source page: https://510kreport.com/device/K053476
Methodology: https://510kreport.com/methodology