510(k) Report

510(k) · Cleared

Cleared

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

K031997510(k) TraditionalCleared Nov 25, 2003151-day reviewClass I21 CFR 868.6810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mallinckrodt Dar S.R.L. · BSY Catheters, Suction, Tracheobronchial

Cleared on Nov 25, 2003 as substantially equivalent to K972258 (Mallinckrodt Medical, 1997) and 3 other predicates after a 151-day review. Its family tree reaches back 1 generation to 1987.

Decided
Nov 25, 2003
Review
151 days
Class
Class I
Product code
BSY
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K873810 (1987). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1997: 2 other ancestorsK873810 · Safety Shield Suction Catheter · Ballard Medical Products · 198719851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors K873810 · Safety Shield Suction Catheter · Ballard Medical Products · 19870
  1. Root · 1 generation backK873810 Safety Shield Suction CatheterBallard Medical Products · 1987
  2. This deviceK031997 Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction SystemMallinckrodt Dar S.R.L. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K873810Safety Shield Suction CatheterBallard Medical Products1987—
0 (this device)K031997Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction SystemMallinckrodt Dar S.R.L.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
FIG. 1 — Lineage of K031997, 1987–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K972258HI-Care Closed Suction System
Summary page 1
…F THE PREDICATE OR LEGALLYMARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEINGCLAIMED MALLINCKRODT DAR HI-CARE(K972258) Ballard (Kimberly Clark) Trach-Care (K974630, K964369, K8738 10) 4. DEVICE DESCRIPTION Ty-Care is a…
Mallinckrodt Medical1997—
*K97463072 Hour Use Trach Care with Microban
Summary page 1
…WHICH EQUIVALENCE IS BEINGCLAIMED MALLINCKRODT DAR HI-CARE(K972258) Ballard (Kimberly Clark) Trach-Care (K974630, K964369, K8738 10) 4. DEVICE DESCRIPTION Ty-Care is a suction catheter system that is designed to connect t…
Ballard Medical Products1998—
*K964369Trach Care Set with Microban
Summary page 1
…UIVALENCE IS BEINGCLAIMED MALLINCKRODT DAR HI-CARE(K972258) Ballard (Kimberly Clark) Trach-Care (K974630, K964369, K8738 10) 4. DEVICE DESCRIPTION Ty-Care is a suction catheter system that is designed to connect to the end…
Ballard Medical Products1997—
*K873810Safety Shield Suction Catheter
Summary page 1
…IS BEINGCLAIMED MALLINCKRODT DAR HI-CARE(K972258) Ballard (Kimberly Clark) Trach-Care (K974630, K964369, K8738 10) 4. DEVICE DESCRIPTION Ty-Care is a suction catheter system that is designed to connect to the endotracheal…
Ballard Medical Products1987—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 4 ancestors has a recall.

How does its category compare?

All BSY devices

BSY Catheters, Suction, Tracheobronchial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSY

FDA has decided no BSY device since 2007.

Median 510(k) review, days · BSY

Too few BSY 510(k)s in any year since 2007 to give a median.

Recalls per year · BSY

1in 2023

2014: 1, 1 Class I2017: 112019: 12020: 12021: 32023: 1
2007high 11 (2017) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSY

163in 2025

2007: 312008: 172009: 372010: 202011: 422012: 542013: 482014: 652015: 2952016: 3152017: 1132018: 7212019: 1212020: 1492021: 632022: 3092023: 1982024: 2102025: 163
2007high 721 (2018) · low 17 (2008)2025

MAUDE reports naming product code BSY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—031
20080—017
20090—037
20100—020
20110—042
20120—054
20130—048
20140—1 (1)65
20150—0295
20160—0315
20170—11113
20180—0721
20190—1121
20200—1149
20210—363
20220—0309
20230—1198
20240—0210
20250—0163
20260—0—

What is it indicated for?

This closed suction system is indicated for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.

Indications for use as stated in the FDA summary.

More from Mallinckrodt Dar S.R.L.

2 FDA decisions under this applicant name. See the company

  • K993268Mallinckrodt Dar Heated Wire Breathing CircuitMallinckrodt Dar S.R.L. · 2000

Recent decisions in BSY

The BSY category page

  • K992902Ambu Hand Power Suction PumpAmbu, Inc. · 1999
  • K982945Dual Purpose Closed CatheterSpirit Medical Systems, Inc. · 1998
  • K981910Suction CatheterNi-Med, Inc. · 1998
  • K972258HI-Care Closed Suction SystemMallinckrodt Medical · 1997
  • K973199Amsino Suction CatheterAmsino Intl., Inc. · 1997

https://510kreport.com/device/K031997 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031997: Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031997

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026