Cleared Traditional

STERILE SALINE FOR CATHETER CARE (K974397) - FDA 510(k) Clearance

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

K974397 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
81d
Days
Class 2
Risk

K974397 is an FDA 510(k) clearance for the STERILE SALINE FOR CATHETER CARE. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K974397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date February 10, 1998
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - JOL Catheter And Tip, Suction

All 10
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K974397.
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
K051370 · Baxter Healthcare Corp · Aug 2005
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
K950201 · Sherwood Medical Co. · Dec 1995
THORACENTESIS CATHETER
K951524 · Baxter Healthcare Corp · Jul 1995
STERILE WATER
K943773 · Medline Industries, Inc. · Feb 1995
DISPOSABLE SUCTION PROBE
K942061 · United States Surgical, A Division of Tyco Healthc · May 1994
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · Baxter Healthcare Corp · Oct 1991