510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031997Substantially Equivalent

Mallinckrodt Dar Ty-Care / Ty-Care Exel Closed Suction System

Mallinckrodt Dar S.r.l., Mirandola (Modena), IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031997 is the FDA 510(k) clearance record for MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM, a class I device, cleared for Mallinckrodt Dar S.R.L. on under FDA product code BSY (Catheters, Suction, Tracheobronchial). FDA records list 2 510(k) clearances for Mallinckrodt Dar S.R.L., from to . As of , FDA records show no recalls naming K031997.

Clearance record

Decision date
Received
(151 days to decision)
Product code
BSY Catheters, Suction, Tracheobronchial
Regulation
21 CFR 868.6810
Device class
Class I
Review panel
Anesthesiology
Applicant
Mallinckrodt Dar S.R.L. Via G.Bove, 2/4/6/8, Mirandola (Modena), IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSY

Trailing 12 months

FDA records hold no clearances under product code BSY in the trailing twelve months.

FDA records show no clearances under product code BSY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260