Cleared Traditional

K952663 - 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP

K952663 is an FDA 510(k) clearance for 60 MICRO VOLUME EXTENSION SET W/.22 MIC..., manufactured by Distronic Sterile Products, Inc.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K952663 · Distronic Sterile Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
32d
Days
Class 2
Risk

K952663 is an FDA 510(k) clearance for the 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIV.... Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Distronic Sterile Products, Inc. (Portsmouth, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 32 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 Distronic Sterile Products, Inc. devices

FDA 510(k) Submission Details - K952663

510(k) Number K952663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date July 14, 1995
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 30
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K952663.
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