510(k) Report

510(k) · Cleared

Cleared

Sorbsan Topical Wound Dressing (Modified)

K914575510(k) TraditionalCleared Dec 4, 199150-day reviewClass I21 CFR 878.4018

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

Dow B. Hickam, Inc. · NAC Dressing, Wound, Hydrophilic

Cleared on Dec 4, 1991 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 335 later devices descend from it.

Decided
Dec 4, 1991
Review
50 days
Class
Class I
Product code
NAC
Recalls
None
Predicates
0

335 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2001: 2 descendants cleared2011: 15 descendants cleared2002: 8 descendants cleared2003: 6 descendants cleared2004: 10 descendants cleared2005: 5 descendants cleared2025: 16 descendants cleared2000: 2 descendants cleared2006: 14 descendants cleared2007: 14 descendants cleared2010: 18 descendants cleared2015: 14 descendants cleared2013: 12 descendants cleared2014: 15 descendants cleared2009: 22 descendants cleared2008: 16 descendants cleared2020: 7 descendants cleared2012: 15 descendants cleared2022: 12 descendants cleared2021: 11 descendants cleared2023: 13 descendants cleared2017: 20 descendants cleared2026: 14 descendants cleared2016: 11 descendants cleared2018: 13 descendants cleared2019: 11 descendants cleared2024: 17 descendants cleared1990200020102020
  1. This deviceK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
  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 335 descendants. See all descendants

Descendants cleared per year

1998: 22000: 22001: 22002: 82003: 62004: 102005: 52006: 142007: 142008: 162009: 222010: 182011: 152012: 152013: 122014: 152015: 142016: 112017: 202018: 132019: 112020: 72021: 112022: 122023: 132024: 172025: 162026: 14
1998high 22 (2009) · low 0 (1999)2026

Most influential descendants

Showing 5 of 335 · 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)K914575Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc.1991—
+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
199820
200020
200120
200280
200360
2004100
200550
2006140
2007140
2008160
2009220
2010180
2011150
2012150
2013120
2014150
2015140
2016110
2017200
2018130
2019110
202070
2021110
2022120
2023130
2024170
2025160
2026140
FIG. 1 — Lineage of K914575, 1991–2026Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NAC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (335)

See all 335

3 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
K983210Algisite MSmith & Nephew, Inc.199884
K004028Arglaes-AB Antimicrobial Barrier Powder DressingMaersk Medical, Ltd.20010

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 NAC devices

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

FDA decisions per year · NAC

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAC

Too few NAC 510(k)s in any year since 2007 to give a median.

Recalls per year · NAC

3in 2024

2016: 12024: 32026 (partial year): 1
2007high 3 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NAC

83in 2025

2010: 22013: 202014: 972015: 2432016: 592017: 262018: 2212019: 672020: 1372021: 572022: 712023: 1152024: 352025: 83
2007high 243 (2015) · low 0 (2007)2025

MAUDE reports naming product code NAC, 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
20070—00
20081—00
20090—00
20100—02
20110—00
20120—00
20130—020
20140—097
20150—0243
20160—159
20170—026
20180—0221
20190—067
20200—0137
20210—057
20220—071
20230—0115
20240—335
20250—083
20260—1—

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https://510kreport.com/device/K914575 · printed Nov 5, 2026

Cite this page

510(k) Report. “K914575: Sorbsan Topical Wound Dressing (Modified).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K914575

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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