510(k) Report

510(k) · Cleared

Cleared

Aqua Patch

K973693510(k) TraditionalCleared Dec 18, 199783-day reviewClass U

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

Pci Technology · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Dec 18, 1997 after an 83-day review. The FDA summary names no predicate by number.

Decided
Dec 18, 1997
Review
83 days
Class
Class U
Product code
MGQ
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K973693Source: FDA 510(k) database · 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?

The FDA summary names no predicate by number.

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.

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?

Dermal ulcers, superficial wounds, 1* and 2™ degree burns, donor sites, skin tears, radiation reactions (burns), protection around tube sites.

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

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/K973693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973693: Aqua Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973693

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026