510(k) Report

510(k) · Cleared

Cleared

Ferris Hydrophilic Dressing

K880330510(k) TraditionalCleared Mar 23, 198856-day reviewClass U

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

Ferris Mfg. Corp. · FRO Dressing, Wound, Drug

Cleared on Mar 23, 1988 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 23, 1988
Review
56 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared1990200020102020
  1. This deviceK880330 Ferris Hydrophilic DressingFerris Mfg. Corp. · 1988
  2. Descendant · cites it directly · 0 of its ownK121361 Curaline Polyurethane Foam Awc DressingCuraline, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K121361Curaline Polyurethane Foam Awc DressingCuraline, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K880330Ferris Hydrophilic DressingFerris Mfg. Corp.1988—
+1K121361Curaline Polyurethane Foam Awc DressingCuraline, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K880330, 1988–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121361Curaline Polyurethane Foam Awc DressingCuraline, Inc.20120

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, K121361 (Curaline, Inc., 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Ferris Mfg. Corp.

20 FDA decisions under this applicant name. See the company

  • K031660Ferris Polymem Sterile Breast PadFerris Mfg. Corp. · 2005
  • K031307Ferris Polymem Silver Wound DressingFerris Mfg. Corp. · 2003
  • K002129Ferris Polymem Sterile Wound Dressing with CollagenFerris Mfg. Corp. · 2000
  • K991729Ferris Polyostomy Sterile Wound DressingFerris Mfg. Corp. · 1999
  • K990906Ferris Polymem Polywic Sterile Cavity Wound FillerFerris Mfg. Corp. · 1999

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/K880330 · printed Nov 4, 2026

Cite this page

510(k) Report. “K880330: Ferris Hydrophilic Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880330

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026