510(k) Report

510(k) · Cleared

Cleared

Carrasyn FDG

K944427510(k) TraditionalCleared Nov 29, 199478-day reviewClass U

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

Carrington Laboratories, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Nov 29, 1994 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided
Nov 29, 1994
Review
78 days
Class
Class U
Product code
MGQ
Recalls
None
Predicates
0

27 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2018: 3 descendants cleared2010: 1 descendant cleared2016: 2 descendants cleared2011: 1 descendant cleared2024: 4 descendants cleared2015: 5 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2025: 2 descendants cleared2019: 1 descendant cleared2017: 2 descendants cleared2026: 3 descendants cleared1990200020102020
  1. This deviceK944427 Carrasyn FDGCarrington Laboratories, Inc. · 1994
  2. Descendant · cites it directly · 26 of its ownK090092 Sockit! and Mcmerlin Dermal Wound GelMcmerlin Dental Products LP · 2009
  3. Descendant · 2 generations on · 25 of its ownK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 17 of its ownK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011
  5. Descendant · 3 generations on · 11 of its ownK123071 Vashe Skin and Wound HydrogelPuricore, Inc. · 2013
  6. Descendant · 3 generations on · 10 of its ownK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12013: 12014: 12015: 52016: 22017: 22018: 32019: 12024: 42025: 22026: 3
2009high 5 (2015) · low 0 (2012)2026

Most influential descendants

Showing 5 of 27 · See all
  • K090092Sockit! and Mcmerlin Dermal Wound GelMcmerlin Dental Products LP · 2009 · cites it directly26descendants
  • K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · 2 generations on25descendants
  • K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011 · 2 generations on17descendants
  • K123071Vashe Skin and Wound HydrogelPuricore, Inc. · 2013 · 3 generations on11descendants
  • K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015 · 3 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944427Carrasyn FDGCarrington Laboratories, Inc.1994—
+1K090092Sockit! and Mcmerlin Dermal Wound GelMcmerlin Dental Products LP2009—
+2K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc.20101
+2K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc.2011—
+3K123071Vashe Skin and Wound HydrogelPuricore, Inc.2013—
+3K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201310
201410
201550
201620
201720
201830
201910
202440
202520
202630
FIG. 1 — Lineage of K944427, 1994–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K090092Sockit! and Mcmerlin Dermal Wound GelMcmerlin Dental Products LP200926

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?

  • Of its descendants, K090092 (Mcmerlin Dental Products LP, 2009) has gone furthest, with 26 descendants of its own.

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—

More from Carrington Laboratories, Inc.

15 FDA decisions under this applicant name. See the company

  • K022670Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
  • K012126The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
  • K983182Aloe Therapy Oral RinseCarrington Laboratories, Inc. · 1998
  • K964852Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
  • K962218Carrasyn Hydrogel Wound Dressing,Carragauze Pads,Carragauze Strips,Carrasorb M FDGCarrington Laboratories, Inc. · 1996

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/K944427 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944427: Carrasyn FDG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944427

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026