Cleared Traditional

VARIOUS TUBING (K943206) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943206 · Prn Services, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
247d
Days
Class 2
Risk

K943206 is an FDA 510(k) clearance for the VARIOUS TUBING. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Prn Services, Inc. (Madison Heights, US). The FDA issued a Cleared decision on March 9, 1995 after a review of 247 days - an extended review cycle.

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 Prn Services, Inc. devices

Submission Details

510(k) Number K943206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date March 09, 1995
Days to Decision 247 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 129d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPK Tubing, Fluid Delivery
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 - FPK Tubing, Fluid Delivery

Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K943206.
LIFESHIELD EXTENSION SET
K912103 · Abbott Laboratories · Dec 1991
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009 · 3M Company · May 1989
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · 3M Company · May 1989
MERIT HI-FLEX(TM)
K883718 · Merit Medical Systems, Inc. · Jan 1989
SAFEED EXTENSION TUBES
K810005 · Terumo Medical Corp. · Feb 1981