Cleared Traditional

PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000265 · Primary Care Solutions, Inc. · General Hospital
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Jul 2001
Decision
531d
Days
Class 2
Risk

K000265 is an FDA 510(k) clearance for the PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Primary Care Solutions, Inc. (Ringwood, US). The FDA issued a Cleared decision on July 12, 2001 after a review of 531 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Primary Care Solutions, Inc. devices

Submission Details

510(k) Number K000265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2000
Decision Date July 12, 2001
Days to Decision 531 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
402d slower than avg
Panel avg: 129d · This submission: 531d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOL Catheter And Tip, Suction

All 83
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K000265.
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
K051370 · Baxter Healthcare Corp · Aug 2005
STERILE SALINE FOR CATHETER CARE
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THORACENTESIS CATHETER
K951524 · Baxter Healthcare Corp · Jul 1995
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · Baxter Healthcare Corp · Oct 1991
SUCTION KIT
K760586 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1976