510(k) · Cleared
ClearedAllwound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
At Squared, LLC · SEJ Wound Dressings Containing Topical Analgesics
Cleared on Jun 26, 2006 as substantially equivalent to K022584 (Cardiotech Intl., 2002) and 2 other predicates after a 194-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jun 26, 2006
- Review
- 194 days
- Class
- Class U
- Product code
- SEJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K935060 (1994). 7 ancestors in all, the oldest K895993 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK935060 Brennen Medical Sterile Saline SolutionBrennen Medical, Inc. · 1994
- 1 generation backK972185 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium ChlorideSteripak, Ltd. · 1998
- This deviceK053476 AllwoundAt Squared, LLC · 2006
- Descendant · cites it directly · 0 of its ownK211943 Microlyte Ag/LidocaineImbed Biosciences · 2024
Most influential descendants
Showing 1 of 1 · See all- K211943Microlyte Ag/LidocaineImbed Biosciences · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935060 | Brennen Medical Sterile Saline Solution | Brennen Medical, Inc. | 1994 | — |
| −1 | K972185 | 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride | Steripak, Ltd. | 1998 | — |
| 0 (this device) | K053476 | Allwound | At Squared, LLC | 2006 | — |
| +1 | K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SEJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K020505 | FDA’s K020505 is Synthes Translating Maxillary Distractor 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…(Unclassified, Product Code MGQ) Predicate Devices: WoundPal is substantially equivalent to the following cleared devices: * Regenecare Wound Gel (MPM Medical, Inc., K02050540) * Cardiotech Antibiotic Hydrogel Wound Dressing (Cardiotech Intl., K022584) * Kendall Keriix MD Antimicrobial Gauze Dres… | 2002 |
| * | K022584 | Cardiotech Antibotic Hydrogel Wound DressingSummary page 1…uivalent to the following cleared devices: * Regenecare Wound Gel (MPM Medical, Inc., K02050540) * Cardiotech Antibiotic Hydrogel Wound Dressing (Cardiotech Intl., K022584) * Kendall Keriix MD Antimicrobial Gauze Dressing (The Kendall Company LP, K990530) * 20mL Normal Saline Topical Sol… | 2002 |
| * | K990530 | Kerlix MD Antimicrobial Gauze DressingSummary page 1…50540) * Cardiotech Antibiotic Hydrogel Wound Dressing (Cardiotech Intl., K022584) * Kendall Keriix MD Antimicrobial Gauze Dressing (The Kendall Company LP, K990530) * 20mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride (Steripak, K972195) Device Description: The proposed… | 2000 |
| * | K972185 | 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride 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”. | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211943 | Microlyte Ag/Lidocaine | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K211943 (Imbed Biosciences, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SEJ devicesSEJ Wound Dressings Containing Topical Analgesics: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · SEJ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · SEJ
Too few SEJ 510(k)s in any year since 2007 to give a median.
Recalls per year · SEJ
No recall names SEJ since 2007.
Adverse event reports per year · SEJ
No MAUDE report names SEJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053476 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053476: Allwound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053476
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026