Cleared Traditional

K944427 - CARRASYN FDG

K944427 · Carrington Laboratories, Inc. · General & Plastic Surgery device

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Nov 1994

Decision

78d

Days

Risk

K944427 is an FDA 510(k) clearance for the CARRASYN FDG. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Carrington Laboratories, Inc. (Irving, US). The FDA issued a Cleared decision on November 29, 1994 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K944427

510(k) Number	K944427 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	September 12, 1994
Decision Date	November 29, 1994
Days to Decision	78 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

37d faster than avg

Panel avg: 115d · This submission: 78d

Pathway characteristics

Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code	MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class	-

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 138

Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K944427.

DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING

K946031 · Wilshire Medical Products · Feb 1995

ARGIDENE(TM) GEL

K945835 · Telios Pharmaceuticals, Inc. · Feb 1995

SPARTA HYDROGEL WOUND DRESSING

K945313 · Sparta Surgical Corp. · Jan 1995

HYDRODERM GEL WOUND DRESSING

K944333 · Wilshire Medical Products · Nov 1994

BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS

K943470 · Levtrade Intl. (Pty) , Ltd. · Sep 1994

BURNFREE BURNSOOTHE HYDROGEL

K943728 · Levtrade Intl. (Pty) , Ltd. · Sep 1994

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K944427

Carrington Laboratories, Inc.

Irving, TX · US

DENNIS R SPARKMAN

Regulatory profile

15 submissions 9 cleared

60% clearance rate · Active in General & Plastic Surgery

View all devices by Carrington Laboratories, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: November 29, 1994. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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