Cleared Traditional

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

K971168 is the FDA 510(k) clearance for ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE by Baxter Healthcare Corp. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 32
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K971168.
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
K982102 · Baxter Healthcare Corp · Sep 1998
PAINBUSTER INFUSION SYSTEM
K980558 · I-Flow Corp. · May 1998
MEDI-SIS SYRINGE INFUSION SYSTEM
K972173 · I-Flow Corp. · Aug 1997
BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET
K955727 · I-Flow Corp. · Feb 1996
TITAN 20 CC DRIVER
K954059 · I-Flow Corp. · Sep 1995
TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET
K953028 · I-Flow Corp. · Sep 1995