510(k) · Cleared
ClearedSURECELL Gelling Fiber Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Newvalue Medical Producst Co.,Ltd · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on May 25, 2018 as substantially equivalent to K070175 (Medtrade Products, Ltd., 2007) after a 240-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- May 25, 2018
- Review
- 240 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914575 (1991). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 5 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 4 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 3 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 2 generations backK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- 1 generation backK070175 Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007
- This deviceK173005 SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −5 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −4 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −3 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −2 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| −1 | K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | Medtrade Products, Ltd. | 2007 | — |
| 0 (this device) | K173005 | SURECELL Gelling Fiber Wound Dressing | Jiangsu Newvalue Medical Producst Co.,Ltd | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K070175 | Aquanova Super-Absorbent Gelling Dressing, OtcSummary page 5…510(K) Summary Device: SURECELLTM Gelling Fiber Wound Dressing Predicate Device: MedTrade Products AQUANOVA Super-Absorbent Dressing (K070175) I. DEVICE DESCRIPTION SURECELLTM Gelling Fiber Wound Dressing is a sterile non-woven wound dressing composed of hydrophili… | 2007 |
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 27 years and passes through 7 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 3 other devices also cite its predicate K070175.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
Under professional medical care, SURECELL Gelling Fiber Wound Dressing may be used for the management of : Leg ulcers (Stage I-IV), Diabetic ulcers , Surgical wounds (e.g. post-operative, donor sites, dermatological) ,Pressure ulcers, Burns (1st and 2nd degree), and Surgical or traumatic wounds which have been left to heal by secondary intention. SURECELL Gelling Fiber Wound Dressing maintains a moist wound environment. SURECELL Gelling Fiber Wound…
Read the full statement (126 words)
Under professional medical care, SURECELL Gelling Fiber Wound Dressing may be used for the management of :
Leg ulcers (Stage I-IV), Diabetic ulcers , Surgical wounds (e.g. post-operative, donor sites, dermatological) ,Pressure ulcers, Burns (1st and 2nd degree), and Surgical or traumatic wounds which have been left to heal by secondary intention.
SURECELL Gelling Fiber Wound Dressing maintains a moist wound environment.
SURECELL Gelling Fiber Wound Dressing may also be used for the local management of wounds such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic wounds.
SURECELL Gelling Fiber Wound Dressing Over-the-Counter is indicated for minor Burns, minor abrasions and minor Lacerations, minor superficial cuts.
SURECELL Gelling Fiber Wound Dressing is intended for the maintenance of a moist wound environment.
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/K173005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173005: SURECELL Gelling Fiber Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173005
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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