510(k) Report

510(k) · Cleared

Cleared

Bionect Cream

K963004510(k) TraditionalCleared Feb 12, 1997194-day reviewClass U

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

Fidia Pharmaceutical Corp. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Feb 12, 1997 as substantially equivalent to K945835 (Telios Pharmaceuticals, Inc., 1995) and 2 other predicates after a 194-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.

Decided
Feb 12, 1997
Review
194 days
Class
Class U
Product code
MGQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K830708 (1983). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1990: 1 other ancestor1999: 1 descendant cleared2018: 1 descendant clearedK830708 · Duo Derm Flex Hydroactive Dressings & · Convatec, A Division of E.R. Squibb & Sons · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants K830708 · Duo Derm Flex Hydroactive Dressings & · Convatec, A Division of E.R. Squibb & Sons · 19830
  1. Root · 1 generation backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
  2. This deviceK963004 Bionect CreamFidia Pharmaceutical Corp. · 1997
  3. Descendant · cites it directly · 0 of its ownK172747 Hyaluronic Acid Topical Wound CreamVirchow Biotech Pvt, Ltd. · 2018
  4. Descendant · cites it directly · 0 of its ownK984262 Modification of Bionect Hydrogel Gauze PadsFidia Pharmaceutical Corp. · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K172747Hyaluronic Acid Topical Wound CreamVirchow Biotech Pvt, Ltd. · 2018 · cites it directly0descendants
  • K984262Modification of Bionect Hydrogel Gauze PadsFidia Pharmaceutical Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830708Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons1983—
0 (this device)K963004Bionect CreamFidia Pharmaceutical Corp.1997—
+1K172747Hyaluronic Acid Topical Wound CreamVirchow Biotech Pvt, Ltd.2018—
+1K984262Modification of Bionect Hydrogel Gauze PadsFidia Pharmaceutical Corp.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
201810
FIG. 1 — Lineage of K963004, 1983–2018Source: 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 MGQ? 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? (3)

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
*K945835Argidene (TM) Gel
Summary page 2
…NECT® Cream is substantially equivalent in function and intended use to the following commercially available non-interactive wound and burn dressings: . Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.) . Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington Laboratories, Inc.) . DuoDERM Hydroac…
Telios Pharmaceuticals, Inc.1995—
*K902345Carrington Wound Dressing
Summary page 2
…following commercially available non-interactive wound and burn dressings: . Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.) . Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington Laboratories, Inc.) . DuoDERM Hydroactive™ Gel (K830708) (ConvaTec.) Device description Explanation of how the d…
Carrington Laboratories, Inc.1990—
*K830708Duo Derm Flex Hydroactive Dressings &
Summary page 2
…gs: . Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.) . Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington Laboratories, Inc.) . DuoDERM Hydroactive™ Gel (K830708) (ConvaTec.) Device description Explanation of how the device functions: BIONECT® Cream acts to provide a moist wound environm…
Convatec, A Division of E.R. Squibb & Sons1983—

Also cleared against K945835: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172747Hyaluronic Acid Topical Wound CreamVirchow Biotech Pvt, Ltd.20180
K984262Modification of Bionect Hydrogel Gauze PadsFidia Pharmaceutical Corp.19990

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K172747 (Virchow Biotech Pvt, Ltd., 2018) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K945835.

How does its category compare?

All MGQ devices

MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGQ

1in 2017

2009: 12017: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MGQ

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

Recalls per year · MGQ

4in 2014

2014: 4
2007high 4 (2014) · low 0 (2007)2026

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

Adverse event reports per year · MGQ

5in 2025

2007: 12009: 22010: 32011: 52012: 12013: 42014: 102015: 32016: 42017: 62018: 22019: 22020: 62021: 12023: 62024: 112025: 5
2007high 11 (2024) · low 0 (2008)2025

MAUDE reports naming product code MGQ, 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
20091—02
20100—03
20110—05
20120—01
20130—04
20140—410
20150—03
20160—04
20171—06
20180—02
20190—02
20200—06
20210—01
20220—00
20230—06
20240—011
20250—05
20260—0—

What is it indicated for?

BIONECT® Cream is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns. The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction, and desiccation.

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 K945835

1 other device cites the same predicate.

  • K984413Bionect HydrogelFidia Pharmaceutical Corp. · 1999

More from Fidia Pharmaceutical Corp.

10 FDA decisions under this applicant name. See the company

  • K984266Modification of Bionect Hydrogel SprayFidia Pharmaceutical Corp. · 1999
  • K984262Modification of Bionect Hydrogel Gauze PadsFidia Pharmaceutical Corp. · 1999
  • K984267Modification of Bionect Hydrogel FoamFidia Pharmaceutical Corp. · 1999
  • K984264Modification of Bionect Clear HydrogelFidia Pharmaceutical Corp. · 1999
  • K984413Bionect HydrogelFidia Pharmaceutical Corp. · 1999

Recent decisions in MGQ

The MGQ category page

  • K171879HylaGuard Moisturizing CreamFounders Science Group, LLC · 2017
  • K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009
  • K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
  • K041268Silversite or CalgitrolAdri · 2004
  • K040019SilversealNoble Fiber Technologies · 2004

https://510kreport.com/device/K963004 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963004: Bionect Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963004

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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