510(k) · Cleared
Recalled · Class II · 2015Suprasorb a +AG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Fibres and Materials, Ltd. · FRO Dressing, Wound, Drug
Cleared on May 1, 2008 as substantially equivalent to K013814 (Convatec, A Division of E.R. Squibb & Sons, 2002) and 1 other predicate after a 344-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- May 1, 2008
- Review
- 344 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914575 (1991). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 3 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 2 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 1 generation backK041316 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004
- This deviceK071442 Suprasorb a +AGSpecialty Fibres and Materials, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK183208 Suprasorb A + Ag “R”Speciality Fibres and Materials, Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183208Suprasorb A + Ag “R”Speciality Fibres and Materials, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −3 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −2 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −1 | K041316 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
| 0 (this device) | K071442 | Suprasorb a +AG | Specialty Fibres and Materials, Ltd. | 2008 | — |
| +1 | K183208 | Suprasorb A + Ag “R” | Speciality Fibres and Materials, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K013814 | Absorbent Antimicrobial Wound DressingSummary page 1…e is currently no classification for this device Predicate Devices Absorbent Antimicrobial Wound Dressing (Aquacel Ag) 510(k) No. K013814 Antimicrobial Alginate Dressing (Maxorb Extra Ag), 510(k) No. K041316 Des… | 2002 |
| * | K041316 | Antimicrobial Alginate DressingSummary page 1…Ag) 510(k) No. K013814 Antimicrobial Alginate Dressing (Maxorb Extra Ag), 510(k) No. K041316 Description of the device Calcium Alginate Dressing with Antibacterial Silver Page… | 2004 |
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 |
|---|---|---|---|
| K183208 | Suprasorb A + Ag “R” | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2015 | Class II | Z-0293-2016 | Labeling False and Misleading | The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K183208 (Speciality Fibres and Materials, Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K013814.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
Suprasorb® A -Ag Calcium Alginate Dressing with Antibacterial Silver can be used for the management of wounds which are:
· Moderately and heavily exuding
· Superficial or
Deep
Such as:
Pressure sores
· Arterial Ulcers
* Venous lower leg ulcers
· Diabetic ulcers
Post-operative wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071442: Suprasorb a +AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071442
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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