510(k) Report

510(k) · Cleared

Cleared

Fibracol Collagen-Alginate Dressing

K925548510(k) TraditionalCleared Jul 13, 1993252-day reviewClass II21 CFR 880.5860

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

Johnson & Johnson Medical, Inc. · FMF Syringe, Piston

Cleared on Jul 13, 1993 after a 252-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 273 later devices descend from it.

Decided
Jul 13, 1993
Review
252 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

273 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 16 descendants cleared2004: 8 descendants cleared1998: 1 descendant cleared2003: 5 descendants cleared2022: 12 descendants cleared2006: 11 descendants cleared2009: 15 descendants cleared2002: 8 descendants cleared2005: 4 descendants cleared2025: 17 descendants cleared2000: 2 descendants cleared2007: 12 descendants cleared2010: 14 descendants cleared2015: 8 descendants cleared2013: 9 descendants cleared2024: 15 descendants cleared2014: 12 descendants cleared2012: 14 descendants cleared2018: 9 descendants cleared2016: 10 descendants cleared2008: 13 descendants cleared2020: 4 descendants cleared2021: 8 descendants cleared2017: 17 descendants cleared2023: 9 descendants cleared2026: 13 descendants cleared2019: 7 descendants cleared1990200020102020
  1. This deviceK925548 Fibracol Collagen-Alginate DressingJohnson & Johnson Medical, Inc. · 1993
  2. Descendant · cites it directly · 253 of its ownK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  3. Descendant · 2 generations on · 235 of its ownK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
  4. Descendant · 3 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  5. Descendant · 4 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  6. Descendant · 4 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003

Showing 5 of 273 descendants. See all descendants

Descendants cleared per year

1998: 12000: 22002: 82003: 52004: 82005: 42006: 112007: 122008: 132009: 152010: 142011: 162012: 142013: 92014: 122015: 82016: 102017: 172018: 92019: 72020: 42021: 82022: 122023: 92024: 152025: 172026: 13
1998high 17 (2017) · low 0 (1999)2026

Most influential descendants

Showing 5 of 273 · See all
  • K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998 · cites it directly253descendants
  • K993948Sis Wound Dressing IICook Biotech, Inc. · 2000 · 2 generations on235descendants
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 3 generations on173descendants
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 4 generations on102descendants
  • K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 4 generations on91descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925548Fibracol Collagen-Alginate DressingJohnson & Johnson Medical, Inc.1993—
+1K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc.1998—
+2K993948Sis Wound Dressing IICook Biotech, Inc.2000—
+3K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+4K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
+4K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200020
200280
200350
200480
200540
2006110
2007120
2008130
2009150
2010140
2011160
2012140
201390
2014120
201580
2016100
2017170
201890
201970
202040
202180
2022120
202390
2024150
2025170
2026130
FIG. 1 — Lineage of K925548, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMF? 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 FMF device

  1. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 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? (273)

See all 273

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc.1998253
K030921Collagen Topical Wound DressingCollagen Matrix, Inc.200328
K111578Coreleader Colla-Algi Fiber Model CawCoreleader Biotech Co., Ltd.20110
K040314HealicollEncoll Corp.20040

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, K982597 (Johnson & Johnson Medical, Inc., 1998) has gone furthest, with 253 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

More from Johnson & Johnson Medical, Inc.

54 FDA decisions under this applicant name. See the company

  • K001690Protectiv Safety Blood Collection NeedleJohnson & Johnson Medical, Inc. · 2000
  • K982641Advanced Nibp ModuleJohnson & Johnson Medical, Inc. · 1999
  • K983362NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
  • K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  • K974080Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 19981 recall

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The FMF category page

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https://510kreport.com/device/K925548 · printed Nov 4, 2026

Cite this page

510(k) Report. “K925548: Fibracol Collagen-Alginate Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925548

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