510(k) Report

510(k) · Cleared

Cleared

Doctors Choice Slow Healing Bandage with Spray on Remover

K082208510(k) TraditionalCleared Dec 1, 2008118-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

Scivolutions, Inc. · NAC Dressing, Wound, Hydrophilic

Cleared on Dec 1, 2008 as substantially equivalent to K032983 (Scivolution, Inc., 2004) and 3 other predicates after a 118-day review. Its family tree reaches back 3 generations to 1999.

Decided
Dec 1, 2008
Review
118 days
Class
Class I
Product code
NAC
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K992817 (1999). 10 ancestors in all, the oldest K840438 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestors1997: 2 other ancestors1993: 2 other ancestors1984: 1 other ancestorK992817 · Antibacterial Adhesive Bandage · William Feinstein & Associates, Inc. · 1999K020318 · Scivolutions Various Antibacterial Bandages · Scivolutions, Inc. · 2003K032983 · Sensitive Skin Antibacterial Bandages · Scivolution, Inc. · 20041980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors K032983 · Sensitive Skin Antibacterial Bandages · Scivolution, Inc. · 2004K020318 · Scivolutions Various Antibacterial Bandages · Scivolutions, Inc. · 2003K992817 · Antibacterial Adhesive Bandage · William Feinstein & Associates, Inc. · 19990
  1. Root · 3 generations backK992817 Antibacterial Adhesive BandageWilliam Feinstein & Associates, Inc. · 1999
  2. 2 generations backK020318 Scivolutions Various Antibacterial BandagesScivolutions, Inc. · 2003
  3. 1 generation backK032983 Sensitive Skin Antibacterial BandagesScivolution, Inc. · 2004
  4. This deviceK082208 Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K992817Antibacterial Adhesive BandageWilliam Feinstein & Associates, Inc.1999—
−2K020318Scivolutions Various Antibacterial BandagesScivolutions, Inc.2003—
−1K032983Sensitive Skin Antibacterial BandagesScivolution, Inc.2004—
0 (this device)K082208Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199320
199720
199820
FIG. 1 — Lineage of K082208, 1999–2008Source: 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 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
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What was it cleared against? (4)

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
*K032983Sensitive Skin Antibacterial Bandages
Summary page 2
…s Class 1 and 5 10(k) exempt. Due to the product modifications the spray on remover this 510(k) is being submitted. Predicate Device: SciVolutions Gentle Care Bandage - K032983 Algoplaque Film Extra Thin Hydrocolloid Dressing - K974348 3M Tegasorb Thin Hydrocollide Dressing - K982892 DuoDerm Extra Thin CG…
Scivolution, Inc.2004—
*K974348Algoplaque Film Extra Thin Hydrocolloid Dressing
Summary page 2
…ons the spray on remover this 510(k) is being submitted. Predicate Device: SciVolutions Gentle Care Bandage - K032983 Algoplaque Film Extra Thin Hydrocolloid Dressing - K974348 3M Tegasorb Thin Hydrocollide Dressing - K982892 DuoDerm Extra Thin CGF Dressing - K973716 Substantial Equivelance:…
Laboratoires Urgo S.A.1998—
*K9828923M Tegasorb Thin Hydrocolloid Dressing
Summary page 2
…mitted. Predicate Device: SciVolutions Gentle Care Bandage - K032983 Algoplaque Film Extra Thin Hydrocolloid Dressing - K974348 3M Tegasorb Thin Hydrocollide Dressing - K982892 DuoDerm Extra Thin CGF Dressing - K973716 Substantial Equivelance:…
3M Company1998—
*K973716Duoderm Extra Thin CGF Dressing
Summary page 2
…ntle Care Bandage - K032983 Algoplaque Film Extra Thin Hydrocolloid Dressing - K974348 3M Tegasorb Thin Hydrocollide Dressing - K982892 DuoDerm Extra Thin CGF Dressing - K973716 Substantial Equivelance: on Remover is a The Scivolutions…
Convatec, A Bristol-Myers Squibb Co.1997—

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 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
  • None of the 10 ancestors has a recall.

How does its category compare?

All NAC devices

NAC Dressing, Wound, Hydrophilic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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—

What is it indicated for?

The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical professional.

Indications for use as stated in the FDA summary.

More from Scivolutions, Inc.

2 FDA decisions under this applicant name. See the company

  • K020318Scivolutions Various Antibacterial BandagesScivolutions, Inc. · 2003

Recent decisions in NAC

The NAC category page

  • K925841Hydrasorb Joyce SpongeAvitar, Inc. · 1993
  • K914575Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
  • K914779Alginate FiberAdri/Technam · 1991

https://510kreport.com/device/K082208 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082208: Doctors Choice Slow Healing Bandage with Spray on Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082208

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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