Cleared Traditional

K952395 - REDI NURSE SYSTEM (RNS) STERILE WATER F...

K952395 is an FDA 510(k) clearance for REDI NURSE SYSTEM (RNS) STERILE WATER F..., manufactured by Contour Fabricators of Florida, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K952395 · Contour Fabricators of Florida, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
85d
Days
Class 1
Risk

K952395 is an FDA 510(k) clearance for the REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Contour Fabricators of Florida, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on August 15, 1995 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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: 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 Contour Fabricators of Florida, Inc. devices

FDA 510(k) Submission Details - K952395

510(k) Number K952395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1995
Decision Date August 15, 1995
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSY Catheters, Suction, Tracheobronchial

All 45
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K952395.
AMBU HAND POWER SUCTION PUMP
K992902 · Ambu, Inc. · Oct 1999
HI-CARE CLOSED SUCTION SYSTEM
K972258 · Mallinckrodt Medical · Dec 1997
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K955831 · Sherwood Medical Co. · Mar 1996
SUCTION CATHETER KIT, STERILE, SINGLE-USE
K951506 · Trinity Laboratories, Inc. · Jul 1995
CONNECTING TUBE
K951745 · Vital Signs, Inc. · May 1995
TRIGUARD(TM) SUCTION SYSTEM
K945950 · Vital Signs, Inc. · Dec 1994