510(k) Report

510(k) · Cleared

Cleared

Curaline Polyurethane Foam Awc Dressing

K121361510(k) TraditionalCleared Nov 30, 2012207-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Curaline, Inc. · FRO Dressing, Wound, Drug

Cleared on Nov 30, 2012 as substantially equivalent to K880330 (Ferris Mfg. Corp., 1988) and 5 other predicates after a 207-day review. Its family tree reaches back 1 generation to 1987.

Decided
Nov 30, 2012
Review
207 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K871166 (1987). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestorK871166 · Allevyn Hydrophilic Polyurethane Dressing · Smith & Nephew, Inc. · 1987198519901995200020052010
Other ancestors, by generation 1 generation back: 5 other ancestors K871166 · Allevyn Hydrophilic Polyurethane Dressing · Smith & Nephew, Inc. · 19870
  1. Root · 1 generation backK871166 Allevyn Hydrophilic Polyurethane DressingSmith & Nephew, Inc. · 1987
  2. This deviceK121361 Curaline Polyurethane Foam Awc DressingCuraline, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K871166Allevyn Hydrophilic Polyurethane DressingSmith & Nephew, Inc.1987—
0 (this device)K121361Curaline Polyurethane Foam Awc DressingCuraline, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199410
199610
199810
FIG. 1 — Lineage of K121361, 1987–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K880330Ferris Hydrophilic Dressing
Summary page 1
…aline Polyurdthane Foam Dressing 5. Legally Marketed Devices to which Substantial Equivalency is Claimed * PolyMem Foam Wound Dressing (Ferris Mfg. Co., K880330, K(900127 and K(932913) Principal Predicate * Allevyn Foam Wound Dressing (Smith-Nephew, K963096 and K(8…
Ferris Mfg. Corp.1988—
*K900127Ferris Hydrophilic Dressing (Add'l Indications)
Summary page 1
…rdthane Foam Dressing 5. Legally Marketed Devices to which Substantial Equivalency is Claimed * PolyMem Foam Wound Dressing (Ferris Mfg. Co., K880330, K(900127 and K(932913) Principal Predicate * Allevyn Foam Wound Dressing (Smith-Nephew, K963096 and K(871166)…
Ferris Mfg. Corp.1990—
*K932913Ferris Polymem Hydrophilic Wound Dressing
Summary page 1
…Legally Marketed Devices to which Substantial Equivalency is Claimed * PolyMem Foam Wound Dressing (Ferris Mfg. Co., K880330, K(900127 and K(932913) Principal Predicate * Allevyn Foam Wound Dressing (Smith-Nephew, K963096 and K(871166) Reference Predic…
Ferris Mfg. Corp.1994—
*K963096Allevyn Hydro Poly Dressing ND All Trac Dressing
Summary page 1
…PolyMem Foam Wound Dressing (Ferris Mfg. Co., K880330, K(900127 and K(932913) Principal Predicate * Allevyn Foam Wound Dressing (Smith-Nephew, K963096 and K(871166) Reference Predicate * Mepilex Foam Wound Dressing (Moilycke Corp., K(983 184) Reference…
Smith & Nephew United, Inc.1996—
*K871166Allevyn Hydrophilic Polyurethane Dressing
Summary page 1
…Wound Dressing (Ferris Mfg. Co., K880330, K(900127 and K(932913) Principal Predicate * Allevyn Foam Wound Dressing (Smith-Nephew, K963096 and K(871166) Reference Predicate * Mepilex Foam Wound Dressing (Moilycke Corp., K(983 184) Reference Pr…
Smith & Nephew, Inc.1987—
*K983184MepilexMolnlycke Health Care, Inc.1998—

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?

  • None of the 6 ancestors has a recall.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

Curaline Polyurethane Foam Dressing is indicated for use in the management of:

* Partial and full thickness wounds

* Pressure ulcers (Stage I-fl')

* Diabetic ulcers

* Acute and chronic venous stasis ulcers

* Arterial ulcers

* Skin grafts; donor and recipient sites

* Burns (1st and 2nd degree)

* Skin tears and avulsions

* Abrasions

* Surgical wounds

* Tube, catheter, drain and I.V. sites

* Dermatologic disorders

* Under compression bandages/wraps

* Traumatic wounds

* Acute and Chronic woonds

* Minimal, moderate and heavily exuding wounds

Indications for use as stated in the FDA summary.

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K121361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121361: Curaline Polyurethane Foam Awc Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121361

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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