510(k) · Cleared
ClearedAugustine 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 Mar 28, 1997 as substantially equivalent to K914207 (Ndm Acquisition Corp., 1991) and 3 other predicates after a 219-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.
- Decided
- Mar 28, 1997
- Review
- 219 days
- Class
- Class I
- Product code
- MSA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K843146 (1984). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK843146 Micro-Temp Pumps & Micro-Temp PadsSeabrook Medical Systems, Inc. · 1984 · Recalled
- This deviceK963293 Augustine Medical Wound Care System Model 68XXXAugustine Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK020077 Modification to Augustine Medical Wound Care System, Model 68XXXAugustine Medical, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K020077Modification to Augustine Medical Wound Care System, Model 68XXXAugustine Medical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843146 | Micro-Temp Pumps & Micro-Temp Pads | Seabrook Medical Systems, Inc. | 1984 | 2 |
| 0 (this device) | K963293 | Augustine Medical Wound Care System Model 68XXX | Augustine Medical, Inc. | 1997 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914207 | Clearsite (R) Sterile Wound Care DressingSummary page 20…The Augustine Medical Wound Care System is substantially equivalent in safety and effectiveness in its intended use to these predicate devices: ClearSite Wound Dressing K914207 & K920677 Manufactured by NDM Corporation, 3040 E. River Road, Dayton, Ohio 45439-1436, (800) 783-1767 Lyofoam Wound Dressing… | 1991 |
| * | K920677 | Clearsite Hydrogel Wound Dressing ModificationSummary page 20…ine Medical Wound Care System is substantially equivalent in safety and effectiveness in its intended use to these predicate devices: ClearSite Wound Dressing K914207 & K920677 Manufactured by NDM Corporation, 3040 E. River Road, Dayton, Ohio 45439-1436, (800) 783-1767 Lyofoam Wound Dressing K860085 M… | 1992 |
| * | K860085 | Lyofoam Wound DressingsSummary page 20…vices: ClearSite Wound Dressing K914207 & K920677 Manufactured by NDM Corporation, 3040 E. River Road, Dayton, Ohio 45439-1436, (800) 783-1767 Lyofoam Wound Dressing K860085 Manufactured by Acme United Corporation, Medical Division, 75 Kings Highway Cutoff, Fairfield, CT 06430-5340, (800) 243-9852 K8… | 1986 |
| * | K843146 | Micro-Temp Pumps & Micro-Temp PadsSummary page 20…783-1767 Lyofoam Wound Dressing K860085 Manufactured by Acme United Corporation, Medical Division, 75 Kings Highway Cutoff, Fairfield, CT 06430-5340, (800) 243-9852 K843146 Manufactured by Seabrook, Inc. 4043 McMann Road, Cincinnati, OH 45245, (800) 477-7757 Augustine Medical, Inc. : 1 === Page 21… | 1984 |
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 |
|---|---|---|---|
| K020077 | Modification to Augustine Medical Wound Care System, Model 68XXX | 2002 | 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?
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K020077 (Augustine Medical, Inc., 2002) has gone furthest, with 0 descendants of its own.
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 to be used for the local management of wounds by maintaining moisture and body temperature in the wound bed and is indicated for partial and full thickness wounds, such as, stage I through IV venous, arterial, diabetic,
and pressure ulcers.
The Augustine Medical Wound Care System is intended to be used for wound care.
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/K963293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963293: Augustine Medical Wound Care System Model 68XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963293
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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