Cleared Traditional

K960223 - CPR YANKAUER

K960223 is an FDA 510(k) clearance for CPR YANKAUER, manufactured by Custom Pack Reliability. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K960223 · Custom Pack Reliability · General Hospital
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Mar 1996
Decision
72d
Days
Class 2
Risk

K960223 is an FDA 510(k) clearance for the CPR YANKAUER. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on March 28, 1996 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K960223

510(k) Number K960223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date March 28, 1996
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
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 - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 66
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K960223.
STRYKER SUCTION REGULATOR
K963648 · Stryker Endoscopy · Nov 1996
RENTON SUCTION DEVICE U.S. PATENT*4,767,404
K962920 · R&S Surgical, LLC · Oct 1996
MEDCARE SUCTION CONNECTING TUBING
K961880 · Medcare Medical Group, Inc. · Jul 1996
MEDCARE YANKAUER SUCTION DEVICE
K954869 · Medcare Custom Packaging, Inc. · Jan 1996
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
K954726 · Stryker Endoscopy · Nov 1995
SUCTION TIP CLEANER CUP
K952219 · Moore/Gobel · Nov 1995
K960223 · CPR YANKAUER
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