510(k) Report

510(k) · Cleared

Cleared

Tielle Plus Hydropolymer Adhesive Dressing

K983234510(k) TraditionalCleared Nov 25, 199871-day reviewClass U

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

Johnson & Johnson Medical, Div. of Ethicon, Inc. · MGP Dressing, Wound And Burn, Occlusive

Cleared on Nov 25, 1998 as substantially equivalent to K973688 (Convatec, Ltd., 1997) after a 71-day review. Its family tree reaches back 1 generation to 1997.

Decided
Nov 25, 1998
Review
71 days
Class
Class U
Product code
MGP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K973688 (1997). No later device cites it as a predicate yet.

K973688 · Duoderm Control Gel Formula Border Dressing · Convatec, Ltd. · 1997199619982000
K973688 · Duoderm Control Gel Formula Border Dressing · Convatec, Ltd. · 19970
  1. Root · 1 generation backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
  2. This deviceK983234 Tielle Plus Hydropolymer Adhesive DressingJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973688Duoderm Control Gel Formula Border DressingConvatec, Ltd.1997—
0 (this device)K983234Tielle Plus Hydropolymer Adhesive DressingJohnson & Johnson Medical, Div. of Ethicon, Inc.1998—
FIG. 1 — Lineage of K983234, 1997–1998Source: 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 MGP? 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? (1)

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
*K973688Duoderm Control Gel Formula Border Dressing
Summary page 1
…NTIAL EQUIVALENCE TIELLE* PLUS Hydropolymer Adhesive Dressing is substantially equivalent and identical in function to DUoDERM* CGF Contro! Gel Formula Border Dressing (K973688) manufactured by ConvaTec — A Division of E.R. Squibb & Sons, Inc. INDICATIONS FOR USE Indications for Use: TIELLE*® PLUS Hydr…
Convatec, Ltd.1997—

Also cleared against K973688: 2 other devices →

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?

  • Its one ancestor has no recall.
  • 2 other devices also cite its predicate K973688.

How does its category compare?

All MGP devices

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

FDA decisions per year · MGP

FDA has decided no MGP device since 2007.

Median 510(k) review, days · MGP

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

Recalls per year · MGP

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MGP

8in 2024

2007: 12009: 12010: 22011: 42013: 72014: 12015: 32016: 12017: 62021: 522022: 32023: 32024: 8
2007high 52 (2021) · low 0 (2008)2025

MAUDE reports naming product code MGP, 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
20080—00
20090—01
20100—02
20110—14
20120—00
20130—07
20140—01
20150—03
20160—01
20170—06
20180—00
20190—00
20200—00
20210—052
20220—03
20230—03
20240—08
20250—00
20260—0—

What is it indicated for?

TIELLE*® PLUS Hydropolymer Dressing is an exudate handling system intended for moderate to heavily exuding wounds. The island dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autotytic debridement thus enabling granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate. TIELLE® PLUS Hydropolymer Dressing is indicated for…

Read the full statement (196 words)

TIELLE*® PLUS Hydropolymer Dressing is an exudate handling system intended for moderate to heavily exuding wounds. The island dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autotytic debridement thus enabling granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate.

TIELLE® PLUS Hydropolymer Dressing is indicated for the management of chronic and acute, moderate to heavily exuding, partial and full thickness wounds including:

s« Superficial wounds

1. Minor abrasions

2. Skin Tears

3. Second Degree Burns

TIELLE* PLUS Hydropolymer Dressing should be used under health care professional directlon for the following indications:

Pressure ulcers

Lower extremity ulcers

1. Venous

2. Arterial

3. Mixed etiology

Diabetic ulcers

Donor sites

TIELLE* PLUS Hydropolymer Dressing is suitable for use under compression bandaging.

PRECAUTIONS

TIELLE PLUS Dressing is not indicated for use on the following:

o Third degree bums

o Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional.

TIELLE PLUS Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K973688

2 other devices cite the same predicate.

  • K983362NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
  • K983394Modification to Tielle Hydropolmer DressingJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1998

More from Johnson & Johnson Medical, Div. of…

5 FDA decisions under this applicant name. See the company

  • K990236Modification of Jelco*,Jelco*-W and Jelco* Plus I.V. Catheters, Cathlon* I.V. Catheters, Optiva* I.V.…Johnson & Johnson Medical, Div. of Ethicon, Inc. · 19991 recall
  • K990395Barrier Surgical GownsJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1999
  • K983240Neutralon PF Powder Free Brown Latex Surgical GlovesJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1998
  • K983394Modification to Tielle Hydropolmer DressingJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1998

Recent decisions in MGP

The MGP category page

  • K012997Collatek FoamBiocore Medical Technologies, Inc. · 2001
  • K012995Collatek SheetBiocore Medical Technologies, Inc. · 2001
  • K001508Laserskin DressingFidia Advanced Biopolymers Srl · 2001
  • K990079Fastseal Chest Wound DressingGreenfield Medical Technologies, Inc. · 1999
  • K991214Simplicare Transparent Wound DressingHollister, Inc. · 1999

https://510kreport.com/device/K983234 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983234: Tielle Plus Hydropolymer Adhesive Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983234

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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