Cleared Traditional

K934258 - SALINE WET DRESSING- STERILE

K934258 · Trinity Laboratories, Inc. · General & Plastic Surgery device
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Nov 1993
Decision
85d
Days
-
Risk

K934258 is an FDA 510(k) clearance for the SALINE WET DRESSING- STERILE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on November 24, 1993 after a review of 85 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 Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K934258

510(k) Number K934258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date November 24, 1993
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
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 256
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K934258.
SALINE DRESSING
K952948 · Busse Hospital Disposables, Inc. · Aug 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995
PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991