Cleared Traditional

K960212 - CPR IRRIGATION TRAY

K960212 is an FDA 510(k) clearance for CPR IRRIGATION TRAY, manufactured by Custom Pack Reliability. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K960212 · Custom Pack Reliability · General Hospital
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Apr 1996
Decision
76d
Days
Class 1
Risk

K960212 is an FDA 510(k) clearance for the CPR IRRIGATION TRAY. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on April 1, 1996 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - 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: 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 Custom Pack Reliability devices

FDA 510(k) Submission Details - K960212

510(k) Number K960212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date April 01, 1996
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYZ Syringe, Irrigating (non Dental)

All 19
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K960212.
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K952407 · Contour Fabricators of Florida, Inc. · Aug 1995
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K940371 · Micromedics, Inc. · Apr 1994