510(k) · Cleared

Cleared

Modification to Tielle Hydropolmer Dressing

K983394510(k) TraditionalCleared Nov 3, 199839-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 3, 1998 as substantially equivalent to K973688 (Convatec, Ltd., 1997) after a 39-day review. Its family tree reaches back 1 generation to 1997.

Decided: Nov 3, 1998
Review: 39 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.

By dateBy generation

Root · 1 generation backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
This deviceK983394 Modification to Tielle Hydropolmer DressingJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973688	Duoderm Control Gel Formula Border Dressing	Convatec, Ltd.	1997	—
0 (this device)	K983394	Modification to Tielle Hydropolmer Dressing	Johnson & Johnson Medical, Div. of Ethicon, Inc.	1998	—

FIG. 1 — Lineage of K983394, 1997–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K973688	Duoderm Control Gel Formula Border Dressing Summary page 1 …ENT OF SUBSTANTIAL EQUIVALENCE , TIELLE* Hydropolymer Dressing is substantially equivalent and identical in function to DuoDERM* CGF Control Gel Formula Border Dressing (K973688) manufactured by ConvaTec — A Division of E.R. Squibb & Sons, Inc. INDICATIONS FOR USE TIELLE* Dressing is indicated for the ma…	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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	0
2009	—	0	1
2010	—	0	2
2011	—	1	4
2012	—	0	0
2013	—	0	7
2014	—	0	1
2015	—	0	3
2016	—	0	1
2017	—	0	6
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	52
2022	—	0	3
2023	—	0	3
2024	—	0	8
2025	—	0	0
2026	—	0	—

What is it indicated for?

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

Read the full statement (187 words)

TIELLE* Hydropolymer Dressing is indicated for the management of chronic and acute, low to moderately exuding, partial and full thickness wounds including:

Superficial wounds

1. Minor abrasions

2. Skin Tears

3. Second Degree Burns

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

Pressure ulcers

Lower extremity ulcers

1. Venous

2. Arterial

3. Mixed etiology

Diabetic ulcers

Donor sites

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

PRECAUTIONS

TIELLE Dressing is not indicated for use on the following:

Third degree burns

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

TIELLE Dressing may be used when visible sugns 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.

https://510kreport.com/device/K983394 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983394: Modification to Tielle Hydropolmer Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983394

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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