Cleared Traditional

K971168 - ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE

K971168 is an FDA 510(k) clearance for ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K971168 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
106d
Days
Class 2
Risk

K971168 is an FDA 510(k) clearance for the ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on July 15, 1997 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K971168

510(k) Number K971168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1997
Decision Date July 15, 1997
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MEB Pump, Infusion, Elastomeric

All 67
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K971168.
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K972158 · Princeton Regulatory Assoc. · Feb 1998
PERSONAL INFUSOR
K971362 · Science Incorporated · Dec 1997
MEDI-SIS SYRINGE INFUSION SYSTEM
K972173 · I-Flow Corp. · Aug 1997
MICROJECT MODEL PCA-1
K965222 · Microject, Inc. · Jun 1997
SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET
K962663 · Solopak Medical Products, Inc. · Oct 1996
SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET
K963355 · Solopak Medical Products, Inc. · Oct 1996