Cleared Traditional

K865089 - FERRIS DYNADERM PLUS

K865089 · Ferris Mfg. Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
36d
Days
-
Risk

K865089 is an FDA 510(k) clearance for the FERRIS DYNADERM PLUS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 36 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.

View all Ferris Mfg. Corp. devices

FDA 510(k) Submission Details - K865089

510(k) Number K865089 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 30, 1986
Decision Date February 04, 1987
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 510
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K865089.
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · American Pharmaseal Div. Ahsc · Jun 1987
BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
K870184 · Fraass Survival Systems, Inc. · Feb 1987
COMPRESS AND BANDAGE, VARIOUS SIZES
K870241 · Fraass Survival Systems, Inc. · Feb 1987
VISCOPASTE ZINC PASTE BANDAGE
K863930 · Smith & Nephew, Inc. · Dec 1986
LYOFOAM C ODOR-ABSORBING DRESSING
K864084 · Acme United Corp. · Nov 1986
CHESEBROUGH POND'S HYDROCOLLOID DRESSING
K862803 · Chesebrough-Pond'S U.S.A. Co. · Nov 1986