510(k) · Cleared
ClearedField Shield Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kericure, Inc. · FRO Dressing, Wound, Drug
Cleared on Jul 18, 2024 as substantially equivalent to K092826 (American Biotech Labs, 2009) and 6 other predicates after a 1,073-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jul 18, 2024
- Review
- 1,073 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K914579 (1992). 81 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- Root · 9 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations between
- 3 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 2 generations backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- 1 generation backK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- This deviceK212521 Field Shield Wound DressingKericure, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 8 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 7 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 6 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 5 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 4 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 3 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 2 generations backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- 1 generation backK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- This deviceK212521 Field Shield Wound DressingKericure, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −8 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −7 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −6 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −5 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −4 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −3 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| −2 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| −1 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| 0 (this device) | K212521 | Field Shield Wound Dressing | Kericure, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 8 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K092826 | Asap Antimicrobial Silver Wound Dressing GelSummary page 5…on Wound Dressing with Drug or Biologic Product Code , Class FRO, Unclassified Primary Predicate ASAP Antibacterial Silver Wound Dressing Gel (K092826) Reference Predicates Amerigel Wound Dressing PLUS (K092086) Puracyn® Plus Duo-CareTM Antimicro… | 2009 |
| * | K092086 | Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model…Summary page 5…, Class FRO, Unclassified Primary Predicate ASAP Antibacterial Silver Wound Dressing Gel (K092826) Reference Predicates Amerigel Wound Dressing PLUS (K092086) Puracyn® Plus Duo-CareTM Antimicrobial Wound & Skin Hydrogel (K150799)… | 2009 |
| * | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Summary page 5…redicates Amerigel Wound Dressing PLUS (K092086) Puracyn® Plus Duo-CareTM Antimicrobial Wound & Skin Hydrogel (K150799) Ionsil Gel (K132326) AcryDerm Antimicrobial Silver Gel Wound Dressing Mode… | 2015 |
| * | K132326 | Ionsil GelSummary page 5…6) Puracyn® Plus Duo-CareTM Antimicrobial Wound & Skin Hydrogel (K150799) Ionsil Gel (K132326) AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B (K083103)… | 2014 |
| * | K083103 | Acryderm Antimicrobial Silver Gel Wound Dressing Model #BSummary page 5…0799) Ionsil Gel (K132326) AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B (K083103) ASAP OTC Wound Dressing Gel (K140483) Silverlon Wound Contact, Burn Contac… | 2009 |
| * | K140483 | Asap Otc Wound Dressing GelSummary page 5…AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B (K083103) ASAP OTC Wound Dressing Gel (K140483) Silverlon Wound Contact, Burn Contact Dressing (K190343)… | 2014 |
| * | K190343 | Silverlon Wound Contact, Burn Contact DressingsSummary page 5…(K083103) ASAP OTC Wound Dressing Gel (K140483) Silverlon Wound Contact, Burn Contact Dressing (K190343) Page 1 of 4… | 2019 |
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 32 years and passes through 9 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 81 ancestors have a recall of any class.
- 1 other device also cites its predicate K092826.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Management of partial and full thickness wounds including stage I - IV pressure ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.
Management of minor wounds including minor cuts, abrasions, lacerations and burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212521: Field Shield 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/K212521
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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