Cleared Traditional

K082330 - PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION

K082330 · Primary Care Solutions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
56d
Days
-
Risk

K082330 is an FDA 510(k) clearance for the PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Primary Care Solutions, Inc. (Zephyrhills, US). The FDA issued a Cleared decision on October 9, 2008 after a review of 56 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 Primary Care Solutions, Inc. devices

FDA 510(k) Submission Details - K082330

510(k) Number K082330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date October 09, 2008
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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