Cleared Traditional

K892440 - KENDALL CURITY EXTENSION TUBES

K892440 is an FDA 510(k) clearance for KENDALL CURITY EXTENSION TUBES, manufactured by The Kendal Co.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K892440 · The Kendal Co. · General Hospital
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Jul 1989
Decision
105d
Days
Class 2
Risk

K892440 is an FDA 510(k) clearance for the KENDALL CURITY EXTENSION TUBES. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on July 24, 1989 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Standard predicate reliance. 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 The Kendal Co. devices

FDA 510(k) Submission Details - K892440

510(k) Number K892440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date July 24, 1989
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K892440.
IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
K894842 · Imed Corp. · Sep 1989
MODIFIED MATERIAL USED IN INFUSION T
K893909 · Quinton, Inc. · Aug 1989
KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
K892438 · The Kendal Co. · Jul 1989
SURFLO(R) WINGED INFUSION SET
K891063 · Terumo Medical Corp. · Jun 1989
TERUMO SURFLO(R) INJECTION PLUG
K891146 · Terumo Medical Corp. · Jun 1989
EXTENSION SET W/FLOW REGULATOR
K890489 · Baxter Healthcare Corp · Jun 1989