510(k) · Cleared
Cleared72 Hour Use Trach Care with Microban
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ballard Medical Products · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Mar 11, 1998 after an 89-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Mar 11, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK974630 72 Hour Use Trach Care with MicrobanBallard Medical Products · 1998
- 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) | K974630 | 72 Hour Use Trach Care with Microban | Ballard Medical Products | 1998 | — |
| +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 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 CAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K956436 | TRACH CARE® Set with MICROBAN® Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…10) 5 French through 18 French TRACH CARE® Closed Suction Endotracheal Suction Catheters with MICROBAN® and various airway connectors. TRACH CARE® Set with MICROBAN® - K9564369 As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent air… |
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 CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, 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 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously…
Read the full statement (141 words)
As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The TRACH CARE® closed suction system, as well as other suction catheters, can also be used for saline lavage and surfactant delivery to the distal airway. The closed system device allows for multiple suction episodes utilizing the same catheter. The protective sleeve of the closed system 1solates the flora from the patient’s secretions, thus reducing the risk of cross-contamination to health care providers and other patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974630: 72 Hour Use Trach Care with Microban.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974630
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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