510(k) · Cleared
ClearedDual Purpose Closed Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spirit Medical Systems, Inc. · BSY Catheters, Suction, Tracheobronchial
Cleared on Sep 22, 1998 as substantially equivalent to K833375 (Jinotti Ent Inc. Medical, 1984) after a 32-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Sep 22, 1998
- Review
- 32 days
- Class
- Class I
- Product code
- BSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833375 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK833375 Dual Purpose CatheterJinotti Ent Inc. Medical · 1984
- This deviceK982945 Dual Purpose Closed CatheterSpirit Medical Systems, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833375 | Dual Purpose Catheter | Jinotti Ent Inc. Medical | 1984 | — |
| 0 (this device) | K982945 | Dual Purpose Closed Catheter | Spirit Medical Systems, Inc. | 1998 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K833375 | Dual Purpose CatheterSummary page 1…n of 21 CFR 868.6810 “Tracheobronchial suction catheter” regulatory Class L Predicate device: The predicate device is Jinotti™ Closed Suction/Oxygen Catheter, (510(k) #K833375) manufactured and distributed by MedCare Medical Group, Inc. Page F-1 DUAL PURPOSE CLOSED CATHETER 510(k) Premar… | 1984 |
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?
- Its one ancestor has no recall.
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 Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient’s trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.
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/K982945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982945: Dual Purpose Closed Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982945
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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