510(k) · Cleared
ClearedHydrasorb Sterile Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avitar, Inc. · MGP Dressing, Wound And Burn, Occlusive
Cleared on Oct 21, 1997 after a 53-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Oct 21, 1997
- Review
- 53 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK973260 Hydrasorb Sterile DressingAvitar, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK070457 Sun Scientific LLC-Leg Compressor and PfabSun Scientific, LLC · 2007
Most influential descendants
Showing 1 of 1 · See all- K070457Sun Scientific LLC-Leg Compressor and PfabSun Scientific, LLC · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973260 | Hydrasorb Sterile Dressing | Avitar, Inc. | 1997 | — |
| +1 | K070457 | Sun Scientific LLC-Leg Compressor and Pfab | Sun Scientific, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 MGP? 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 |
|---|---|---|---|
| * | — | Lyofoam Sterile Dressings Named without a submission number | |
| * | — | Epi-Lock Wound Dressings Named without a submission number | |
| * | — | Allevyn Hydrophilic Polyurethane Foam Named without a submission number | |
| * | — | Hydrasorb Sterile Dressings distributed by Calgon Vestal Named without a submission number |
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 |
|---|---|---|---|
| K070457 | Sun Scientific LLC-Leg Compressor and Pfab | 2007 | 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?
- Of its descendants, K070457 (Sun Scientific, LLC, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MGP devicesMGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGP
FDA has decided no MGP device since 2007.
Median 510(k) review, days · MGP
Too few MGP 510(k)s in any year since 2007 to give a median.
Recalls per year · MGP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGP
8in 2024
MAUDE reports naming product code MGP, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 52 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Avitar Hydrasorb Sterile Dressings are external wound dressings designed to provide a moist healing environment, manage exudate, and protect the wound from contamination. Hydrasorb Sterile Dressings are indicated as external wound dressings for use in the local management of external wounds such as post surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, other external wounds…
Read the full statement (151 words)
Avitar Hydrasorb Sterile Dressings are external wound dressings designed to provide a moist healing environment, manage exudate, and protect the wound from contamination.
Hydrasorb Sterile Dressings are indicated as external wound dressings for use in the local management of external wounds such as post surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, other external wounds inflicted by trauma, and as a secondary dressing or cover dressing for packed wounds.
Hydrasorb Sterile Dressing -Fenestrated also absorbs fluid quickly and efficiently and maintains a moist wound healing environment. It is an ideal dressing in the local management of exudate that may occur at surgically induced body drainage sites such as a tracheostomy, G-tube, J-tube, Penrose drain, chest tube, nephrotomy tube, or sump drain. In general it can be used anywhere there is a need to manage the surrounding skin due to potential skin irritation or maceration.
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/K973260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973260: Hydrasorb Sterile Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973260
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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