Cleared Traditional

K923972 - OPHTHALMIC FLUID DISTRIBUTION SETS

K923972 is an FDA 510(k) clearance for OPHTHALMIC FLUID DISTRIBUTION SETS, manufactured by Visitec Co.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K923972 · Visitec Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
89d
Days
Class 2
Risk

K923972 is an FDA 510(k) clearance for the OPHTHALMIC FLUID DISTRIBUTION SETS. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on November 4, 1992 after a review of 89 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 Visitec Co. devices

FDA 510(k) Submission Details - K923972

510(k) Number K923972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1992
Decision Date November 04, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
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 21
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K923972.
MEDRAD TRANSFER SET
K022431 · Medrad, Inc. · Sep 2002
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RECONSTITUTION ACCESSOREIS
K950861 · Organon, Inc. · May 1995
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