Cleared Traditional

K810185 - IRRIGATION SYRINGE

K810185 is an FDA 510(k) clearance for IRRIGATION SYRINGE, manufactured by Karoco Intl.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K810185 · Karoco Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
381d
Days
Class 2
Risk

K810185 is an FDA 510(k) clearance for the IRRIGATION SYRINGE. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Karoco Intl. (Walker, US). The FDA issued a Cleared decision on January 25, 1982 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Karoco Intl. devices

FDA 510(k) Submission Details - K810185

510(k) Number K810185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1981
Decision Date January 25, 1982
Days to Decision 381 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 129d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FQH Device Classification - Class 2, Special Controls

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
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.