Cleared Traditional

K811107 - IV SETS

K811107 is an FDA 510(k) clearance for IV SETS, manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K811107 · Critikon Company, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
50d
Days
Class 2
Risk

K811107 is an FDA 510(k) clearance for the IV SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Critikon Company, LLC (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 50 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K811107

510(k) Number K811107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1981
Decision Date June 12, 1981
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 540
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K811107.
I.V. ADMINISTRATION SET
K811837 · Medisystems Corp. · Jul 1981
RADIATION STERILIZED ADMIN. SET
K811078 · Travenol Laboratories, S.A. · Jul 1981
I.V. ADMINISTRATION SET
K811685 · Quest Medical, Inc. · Jun 1981
AUTO-SYRINGE MICRO VOLUME EXTENSION SET
K811463 · Baxter Healthcare Corp · Jun 1981
MODELS: 52-01-0, 52-01-1
K811110 · Y · Jun 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239 · Abbott Laboratories · May 1981