Cleared Traditional

K992074 - MPM REGENECARE WOUND GEL

K992074 · Mpm Medical., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
188d
Days
-
Risk

K992074 is an FDA 510(k) clearance for the MPM REGENECARE WOUND GEL. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Mpm Medical., Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 23, 1999 after a review of 188 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Mpm Medical., Inc. devices

FDA 510(k) Submission Details - K992074

510(k) Number K992074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1999
Decision Date December 23, 1999
Days to Decision 188 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 115d · This submission: 188d
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 87
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K992074.
MACROPRO GEL
K000518 · Brennen Medical, Inc. · May 2000
GLUCANPRO
K000519 · Brennen Medical, Inc. · May 2000
MEDLINE TENDER WET WOUND DRESSING
K991755 · Medline Industries, Inc. · Apr 2000
STERILE HYDROGEL
K993119 · Dumex Medical Surgical Products, Ltd. · Nov 1999
BURNFREE PAIN RELIEVING GEL, MODEL 4B
K990178 · Nortrade Medical, Inc. · Aug 1999
BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
K990179 · Nortrade Medical, Inc. · Aug 1999