Cleared Traditional

K952243 - EXTENSION SET/I.V. SET

K952243 is an FDA 510(k) clearance for EXTENSION SET/I.V. SET, manufactured by Coast Medical, Inc.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K952243 · Coast Medical, Inc. · General Hospital
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Jul 1995
Decision
75d
Days
Class 2
Risk

K952243 is an FDA 510(k) clearance for the EXTENSION SET/I.V. SET. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Coast Medical, Inc. (Orange, US). The FDA issued a Cleared decision on July 26, 1995 after a review of 75 days - a notably fast clearance 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: 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 Coast Medical, Inc. devices

FDA 510(k) Submission Details - K952243

510(k) Number K952243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1995
Decision Date July 26, 1995
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPK Device Classification - Class 2, Special Controls

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

All 31
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K952243.
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · Medtronic Minimed · Feb 1997
SILCLEAR TUBING (MODIFICATION)
K953864 · Degania Silicone , Ltd. · Nov 1995
SYSMEX SF-3000
K950508 · Sysmex Corp. · Nov 1995
RECONSTITUTION ACCESSOREIS
K950861 · Organon, Inc. · May 1995
SILCLEAR TUBING
K943992 · Degania Silicone , Ltd. · Mar 1995
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972 · Visitec Co. · Nov 1992