510(k) Report

510(k) · Cleared

Cleared

Dermastream

K060046510(k) TraditionalCleared Feb 27, 200652-day reviewClass I21 CFR 878.4020

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

Enzysurge, Ltd. · NAD Dressing, Wound, Occlusive

Cleared on Feb 27, 2006 as substantially equivalent to K020781 (Kinetic Concepts, Inc., 2002) and 3 other predicates after a 52-day review. Its family tree reaches back 4 generations to 1981. 1 later device descends from it.

Decided
Feb 27, 2006
Review
52 days
Class
Class I
Product code
NAD
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K811291 (1981). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1997: 3 other ancestors1990: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor2009: 1 descendant clearedK811291 · Tegaderm Transparent Dressing · 3M Company · 1981K961319 · Epiview · Convatec, A Division of E.R. Squibb & Sons · 1996K991214 · Simplicare Transparent Wound Dressing · Hollister, Inc. · 1999K020781 · Wet Chamber · Kinetic Concepts, Inc. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 1 descendant K020781 · Wet Chamber · Kinetic Concepts, Inc. · 2002K991214 · Simplicare Transparent Wound Dressing · Hollister, Inc. · 1999K961319 · Epiview · Convatec, A Division of E.R. Squibb & Sons · 1996K811291 · Tegaderm Transparent Dressing · 3M Company · 19810
  1. Root · 4 generations backK811291 Tegaderm Transparent Dressing3M Company · 1981
  2. 3 generations backK961319 EpiviewConvatec, A Division of E.R. Squibb & Sons · 1996
  3. 2 generations backK991214 Simplicare Transparent Wound DressingHollister, Inc. · 1999
  4. 1 generation backK020781 Wet ChamberKinetic Concepts, Inc. · 2002
  5. This deviceK060046 DermastreamEnzysurge, Ltd. · 2006
  6. Descendant · cites it directly · 0 of its ownK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K091133Aplion Topical Care SystemAplion Medical,Llc · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K811291Tegaderm Transparent Dressing3M Company1981—
−3K961319EpiviewConvatec, A Division of E.R. Squibb & Sons1996—
−2K991214Simplicare Transparent Wound DressingHollister, Inc.1999—
−1K020781Wet ChamberKinetic Concepts, Inc.2002—
0 (this device)K060046DermastreamEnzysurge, Ltd.2006—
+1K091133Aplion Topical Care SystemAplion Medical,Llc2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199310
199410
199510
199730
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K060046, 1981–2009Source: 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 NAD? 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 NAD device

  1. #1 K254246 LT Antibacterial Foam with Silver Dressingscore 13.5 · 6 generations · no Class I recall
Get a 510(k) Report

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
*K020781Wet Chamber
Summary page 1
…TM Name: 21 CFR 878.4020- Trade-name of device: DermaStreaM 3. Predicate Device: KCl Wound Cell Transparent Wound Dressing (K020781) 3M Tegaderm Transparent Dressing (K973036 & K901845) KCI V.AC. Insti…
Kinetic Concepts, Inc.2002—
*K9730363M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)…
Summary page 1
…f device: DermaStreaM 3. Predicate Device: KCl Wound Cell Transparent Wound Dressing (K020781) 3M Tegaderm Transparent Dressing (K973036 & K901845) KCI V.AC. Instillamat (K021501) 4. Description: The DermaStreamm is an oc…
3M Healthcare1997—
*K901845Tegaderm Brand Transparent Dressing Series 16XX
Summary page 1
…DermaStreaM 3. Predicate Device: KCl Wound Cell Transparent Wound Dressing (K020781) 3M Tegaderm Transparent Dressing (K973036 & K901845) KCI V.AC. Instillamat (K021501) 4. Description: The DermaStreamm is an occlusive wo…
3M Company1990—
*K021501V.a.C. Instillamat (Vacuum Assisted Closure Instillamat
Summary page 1
…nsparent Wound Dressing (K020781) 3M Tegaderm Transparent Dressing (K973036 & K901845) KCI V.AC. Instillamat (K021501) 4. Description: The DermaStreamm is an occlusive wound dressing which permits the i…
Kinetic Concepts, Inc.2002—

Also cleared against K020781: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K091133Aplion Topical Care SystemAplion Medical,Llc20090

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 25 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
  • None of the 13 ancestors has a recall.
  • Of its descendants, K091133 (Aplion Medical,Llc, 2009) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K020781.

How does its category compare?

All NAD devices

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

FDA decisions per year · NAD

1in 2011

2008: 22009: 12011: 12026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAD

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

Recalls per year · NAD

1in 2025

2010: 12014: 12018: 62022: 12025: 1
2007high 6 (2018) · low 0 (2007)2026

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

Adverse event reports per year · NAD

2,619in 2025

2007: 12008: 82009: 92010: 302011: 92012: 32013: 152014: 632015: 2512016: 1062017: 1342018: 1,0292019: 5882020: 5,0352021: 4512022: 4032023: 1,6192024: 1,8042025: 2,619
2007high 5,035 (2020) · low 1 (2007)2025

MAUDE reports naming product code NAD, 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—01
20082—08
20091—09
20100—130
20111—09
20120—03
20130—015
20140—163
20150—0251
20160—0106
20170—0134
20180—61,029
20190—0588
20200—05,035
20210—0451
20220—1403
20230—01,619
20240—01,804
20250—12,619
20261—0—

What is it indicated for?

The DermaStream Tm is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.

Indications for use as stated in the FDA summary.

Also cleared against K020781

2 other devices cite the same predicate.

  • K091133Aplion Topical Care SystemAplion Medical,Llc · 2009
  • K043063Oxyband Wound DressingOxyband Technologies, Inc. · 2005

More from Enzysurge, Ltd.

3 FDA decisions under this applicant name. See the company

  • K200767SilverStream GelEnzysurge, Ltd. · 2020
  • K093227Silverstream and DermaseptEnzysurge, Ltd. · 2009

Recent decisions in NAD

The NAD category page

  • K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2026
  • K102403Sam Chest Seal with Vavle; Sam Chest SealSam Medical Products · 20111 recall
  • K091133Aplion Topical Care SystemAplion Medical,Llc · 2009
  • K072560Envela (Hydrohesive Occlusive Dressing)Teikoku Pharma USA, Inc. · 2008
  • K080524Centurion Sorbaview OtcTri-State Hospital Supply Corp. · 2008

https://510kreport.com/device/K060046 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060046: Dermastream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060046

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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