Cleared Traditional

K031997 - MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM

K031997 is an FDA 510(k) clearance for MALLINCKRODT DAR TY-CARE / TY-CARE EXEL..., manufactured by Mallinckrodt Dar S.R.L.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K031997 · Mallinckrodt Dar S.R.L. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
151d
Days
Class 1
Risk

K031997 is an FDA 510(k) clearance for the MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Mallinckrodt Dar S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on November 25, 2003 after a review of 151 days - an extended review 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: 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 Mallinckrodt Dar S.R.L. devices

FDA 510(k) Submission Details - K031997

510(k) Number K031997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2003
Decision Date November 25, 2003
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
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 70
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K031997.
AMBU HAND POWER SUCTION PUMP
K992902 · Ambu, Inc. · Oct 1999
DUAL PURPOSE CLOSED CATHETER
K982945 · Spirit Medical Systems, Inc. · Sep 1998
SUCTION CATHETER
K981910 · Ni-Med, Inc. · Aug 1998
HI-CARE CLOSED SUCTION SYSTEM
K972258 · Mallinckrodt Medical · Dec 1997
AMSINO SUCTION CATHETER
K973199 · Amsino Intl., Inc. · Sep 1997
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
K961707 · Sorenson Critical Care · Mar 1997