Cleared Traditional

K864949 - INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAA...

K864949 is the FDA 510(k) clearance for INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAA... by Quinton, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K864949 · Quinton, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
82d
Days
Class 2
Risk

K864949 is an FDA 510(k) clearance for the INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on February 25, 1987 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Quinton, Inc. devices

Submission Details

510(k) Number K864949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date February 25, 1987
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 271
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K864949.
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987
CHURCHILL-CATH
K872585 · Churchill Corp. · Oct 1987
CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE
K870403 · Burron Medical Products, Inc. · May 1987
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153 · Arrow Intl., Inc. · Dec 1986
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
K861725 · Parke-Davis Co. · Dec 1986
COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.
K862130 · Menlo Care, Inc. · Aug 1986