Cleared Traditional

K910453 - TOPS NEEDLE TIP PROBE & PVC TIP PROBE

K910453 is an FDA 510(k) clearance for TOPS NEEDLE TIP PROBE & PVC TIP PROBE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Anesthesiology device with product code CCE cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K910453 · Baxter Healthcare Corp · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
193d
Days
Class 2
Risk

K910453 is an FDA 510(k) clearance for the TOPS NEEDLE TIP PROBE & PVC TIP PROBE. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on August 13, 1991 after a review of 193 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1200 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K910453

510(k) Number K910453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1991
Decision Date August 13, 1991
Days to Decision 193 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 140d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCE Device Classification - Class 2, Special Controls

Product Code CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1200
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

All 15
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K910453.
VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
K935778 · Via Medical Corp. · Dec 1996
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
K912145 · S & W Medico Teknik · May 1992
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
K905397 · Puritan Bennett Corp. · May 1991
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
K890624 · Baxter Healthcare Corp · Dec 1989
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K895149 · Shiley, Inc. · Nov 1989
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
K895150 · Shiley, Inc. · Nov 1989