510(k) · Cleared
ClearedModification to Augustine Medical Wound Care System, Model 68XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augustine Medical, Inc. · MSA Dressing, Wound And Burn, Occlusive, Heated
Cleared on Jan 31, 2002 as substantially equivalent to K963293 (Augustine Medical, Inc., 1997) after a 22-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Jan 31, 2002
- Review
- 22 days
- Class
- Class I
- Product code
- MSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K843146 (1984). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK843146 Micro-Temp Pumps & Micro-Temp PadsSeabrook Medical Systems, Inc. · 1984 · Recalled
- 1 generation backK963293 Augustine Medical Wound Care System Model 68XXXAugustine Medical, Inc. · 1997
- This deviceK020077 Modification to Augustine Medical Wound Care System, Model 68XXXAugustine Medical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K843146 | Micro-Temp Pumps & Micro-Temp Pads | Seabrook Medical Systems, Inc. | 1984 | 2 |
| −1 | K963293 | Augustine Medical Wound Care System Model 68XXX | Augustine Medical, Inc. | 1997 | — |
| 0 (this device) | K020077 | Modification to Augustine Medical Wound Care System, Model 68XXX | Augustine Medical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 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 MSA? 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963293 | Augustine Medical Wound Care System Model 68XXXSummary page 5…me: Augustine Medical Wound Care System Classification name: Dressing, Wound & Burn, Occlusive Equivalent marketed device: Augustine Medical Wound Cover, Model 68XXX, (K963293) Device description: The Augustine Medical wound cover is part of the Wound Care System, which includes a power supply/battery… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All MSA devicesMSA Dressing, Wound And Burn, Occlusive, Heated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSA
FDA has decided no MSA device since 2007.
Median 510(k) review, days · MSA
Too few MSA 510(k)s in any year since 2007 to give a median.
Recalls per year · MSA
No recall names MSA since 2007.
Adverse event reports per year · MSA
1in 2024
MAUDE reports naming product code MSA, not matched to any one device; reports are not rates.
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 | 0 | — | 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 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Augustine Medical Wound Care System is intended for the local management of wounds by maintaining moisture and body temperature in the wound bed. It is indicated for partial- and full-thickness wounds, such as venous, arterial and diabetic ulcers, and Stage II through Stage IV pressure ulcers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020077 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020077: Modification to Augustine Medical Wound Care System, Model 68XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020077
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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