510(k) · Cleared
ClearedArgyle Aspr-Care Closed Suction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · BSY Catheters, Suction, Tracheobronchial
Cleared on Mar 28, 1996 after a 93-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Mar 28, 1996
- Review
- 93 days
- Class
- Class I
- Product code
- BSY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK955831 Argyle Aspr-Care Closed Suction SystemSherwood Medical Co. · 1996
- Descendant · cites it directly · 0 of its ownK972139 Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction…Davis & Geck, Inc. · 1997
Most influential descendants
Showing 1 of 1 · See all- K972139Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope…Davis & Geck, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955831 | Argyle Aspr-Care Closed Suction System | Sherwood Medical Co. | 1996 | — |
| +1 | K972139 | Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction… | Davis & Geck, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ballard Medical Products Trach Care™ Closed Suction System Named without a submission number | |
| * | — | Concord/Portex Steri-Cath™ Closed Suction System Named without a submission number | |
| * | — | Portex Fiberoptic Swivel Adapter Named without a submission number | |
| * | — | Argyle® Lukens Specimen Container Named without a submission number |
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 |
|---|---|---|---|
| K972139 | Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope… | 1997 | 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, K972139 (Davis & Geck, Inc., 1997) 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?
The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.
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/K955831 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955831: Argyle Aspr-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/K955831
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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