Cleared Traditional

ARROW HANDS-OFF THERMO-PACE (K895268) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895268 · Arrow Intl., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
75d
Days
Class 2
Risk

K895268 is an FDA 510(k) clearance for the ARROW HANDS-OFF THERMO-PACE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on November 6, 1989 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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 Arrow Intl., Inc. devices

Submission Details

510(k) Number K895268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1989
Decision Date November 06, 1989
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 156
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K895268.
CORDIS SHUTTLE CATHETER
K896308 · Cordis Corp. · Mar 1990
MULTILUMEN CENTRAL VENOUS CATHETER
K885221 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168 · Baxter Healthcare Corp · Nov 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580 · Boston Scientific Corp · Aug 1989
USCI 7F GUIDE CATHETER
K890420 · C.R. Bard, Inc. · Apr 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502 · C.R. Bard, Inc. · Jan 1989