Cleared Traditional

K910471 - MEDID-VAC CLEAR NONCONDUCTIVE CONNECTIN...

K910471 is the FDA 510(k) clearance for MEDID-VAC CLEAR NONCONDUCTIVE CONNECTIN... by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code GAZ) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K910471 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
32d
Days
Class 2
Risk

K910471 is an FDA 510(k) clearance for the MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE. Classified as Tubing, Noninvasive (product code GAZ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on March 8, 1991 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 880.6740 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K910471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1991
Decision Date March 08, 1991
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAZ Tubing, Noninvasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - GAZ Tubing, Noninvasive

All 11
Devices cleared under the same product code (GAZ) and FDA review panel - the closest regulatory comparables to K910471.
SUCTION/IRRIGATOR TUBING KIT
K952605 · Surgical Laser Technologies, Inc. · Sep 1995
5 - IN - 1 CONNECTOR
K864964 · Medovations, Inc. · Jan 1987
STERILE 5 IN 1 CONNECTORS
K830835 · Abco Dealers, Inc. · Apr 1983
STERILE SAFETY PINS
K830381 · Devon Industries, Inc. · Mar 1983
PLEUROFIX THORACENTESIS KIT
K820004 · Burron Medical Products, Inc. · Feb 1982
ARGYLE CONNECT TUBE-CON & NON
K802777 · Sherwood Medical Co. · Dec 1980