510(k) · Cleared
ClearedHI-Care Closed Suction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Medical · BSY Catheters, Suction, Tracheobronchial
Cleared on Dec 29, 1997 after a 195-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 29, 1997
- Review
- 195 days
- Class
- Class I
- Product code
- BSY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK972258 HI-Care Closed Suction SystemMallinckrodt Medical · 1997
- Descendant · cites it directly · 0 of its ownK031997 Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction SystemMallinckrodt Dar S.R.L. · 2003
Most influential descendants
Showing 1 of 1 · See all- K031997Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction SystemMallinckrodt Dar S.R.L. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972258 | HI-Care Closed Suction System | Mallinckrodt Medical | 1997 | — |
| +1 | K031997 | Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction System | Mallinckrodt Dar S.R.L. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031997 | Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction System | 2003 | 0 |
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?
- Of its descendants, K031997 (Mallinckrodt Dar S.R.L., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BSY devicesBSY 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
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSY
163in 2025
MAUDE reports naming product code BSY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 31 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 37 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 54 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 1 (1) | 65 |
| 2015 | 0 | — | 0 | 295 |
| 2016 | 0 | — | 0 | 315 |
| 2017 | 0 | — | 11 | 113 |
| 2018 | 0 | — | 0 | 721 |
| 2019 | 0 | — | 1 | 121 |
| 2020 | 0 | — | 1 | 149 |
| 2021 | 0 | — | 3 | 63 |
| 2022 | 0 | — | 0 | 309 |
| 2023 | 0 | — | 1 | 198 |
| 2024 | 0 | — | 0 | 210 |
| 2025 | 0 | — | 0 | 163 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions.
This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972258 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972258: HI-Care Closed Suction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972258
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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