Cleared Traditional

K955896 - MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11

K955896 is an FDA 510(k) clearance for MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11, manufactured by Critical Device Corp.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K955896 · Critical Device Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
39d
Days
Class 2
Risk

K955896 is an FDA 510(k) clearance for the MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Critical Device Corp. (Brea, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 39 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.

FDA 510(k) Submission Details - K955896

510(k) Number K955896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1995
Decision Date February 06, 1996
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 179
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K955896.
FORMULATION PREPARATION DEVICE
K955398 · B.Braun Medical, Inc. · Apr 1996
SAFELINE I.V. BAG ACCESS DEVICE
K955594 · Mcgaw, Inc. · Mar 1996
SAFELINE MULTIDOSE VIAL ADAPTER
K955595 · Mcgaw, Inc. · Mar 1996
QTMICRO(TM) SYSTEM
K950305 · Q.I. Medical, Inc. · Oct 1995
IV TRANSFER SPIKE
K943095 · Migada, Ltd. · Sep 1994
DISPENSING PIN WITH ONE-WAY VALVE
K943181 · B. Braun of America, Inc. · Sep 1994
K955896 · MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
Download PDF FDA Summary Critical Device Corp.