Cleared Traditional

K925588 - NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI

K925588 · North American Sterilization & Packaging Co. · General & Plastic Surgery device
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Dec 1993
Decision
393d
Days
-
Risk

K925588 is an FDA 510(k) clearance for the NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI.

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K925588

510(k) Number K925588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date December 03, 1993
Days to Decision 393 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
278d slower than avg
Panel avg: 115d · This submission: 393d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 52
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K932714 · Surface Mount Technology, Inc. · Dec 1993
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K931153 · Igea, S.R.L. · Nov 1993
K925588 · NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
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