Cleared Traditional

K000265 - PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

K000265 is an FDA 510(k) clearance for PRIMARY CARE SOLUTIONS STERILE WATER DE..., manufactured by Primary Care Solutions, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 531-day FDA review.

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

FDA 510(k) Submission Details - K000265

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
Combination Product No
PCCP Authorized No
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.

JOL Device Classification - Class 2, Special Controls

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 51
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
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
K000266 · Primary Care Solutions, Inc. · Jul 2001
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
K994321 · Automatic Liquid Packaging, Inc. · Oct 2000
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
K974758 · Hydrox Laboratories · Mar 1998
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
K974759 · Hydrox Laboratories · Mar 1998
STERILE SALINE FOR CATHETER CARE
K974397 · Baxter Healthcare Corp · Feb 1998