510(k) · Cleared
ClearedSpirtius Cuff Inflation Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spiritus Technologies, LLC · BSK Cuff, Tracheal Tube, Inflatable
Cleared on May 25, 2012 as substantially equivalent to K912723 (Posey Co., 1991) and 3 other predicates after a 235-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- May 25, 2012
- Review
- 235 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K791045 (1979). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK791045 Model GV-10 Lanz Pressure-ValveExtracorporeal Medical Specialities, Inc. · 1979
- This deviceK112915 Spirtius Cuff Inflation SyringeSpiritus Technologies, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791045 | Model GV-10 Lanz Pressure-Valve | Extracorporeal Medical Specialities, Inc. | 1979 | — |
| 0 (this device) | K112915 | Spirtius Cuff Inflation Syringe | Spiritus Technologies, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 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 BSK? 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 BSK device
- #1 K261499 TrachFlushscore 13.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K912723 | Posey CufflatorSummary page 1…Inflatable Tracheal Tube Cuff (accessory) BSK - 868.5750 Predicate Devices: Posey Cufflatorg® - K912723 Mallinckrodt Tracheal Tube Cuff - K88521 6 Ma… | 1991 |
| * | K885216 | Attachable Lanz (Tentative)Summary page 1…BSK - 868.5750 Predicate Devices: Posey Cufflatorg® - K912723 Mallinckrodt Tracheal Tube Cuff - K88521 6 Mallinckrodt Lanz Tracheal Tube Cuff - K791045 Device Description: The Spiritus Cuff… | 1989 |
| * | K791045 | Model GV-10 Lanz Pressure-ValveSummary page 1…723 Mallinckrodt Tracheal Tube Cuff - K88521 6 Mallinckrodt Lanz Tracheal Tube Cuff - K791045 Device Description: The Spiritus Cuff Inflation Syringe (SCIS) is a disposable syringe that will initially inflate the cuff on… | 1979 |
| * | K871204 | Cuffed Tracheal Tube (Multiple)Summary page 3…subsequent use of Minimum Occluding Volume and Minimum Leak techniques in conjunction with an irftra-cuff pressure measuring device. Mallinckrodt Hi-Lo Tracheal Tube (1(871204).-- The materials found in the cuff inflation valve of the Hi- Lo Tracheal Tube include a stainless steel spring, a plastic housi… | 1987 |
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?
- 1 of the 4 ancestors has a recall of any class.
- 5 other devices also cite its predicate K912723.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · BSK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSK
376in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSK
1in 2017
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSK
46in 2025
MAUDE reports naming product code BSK, 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 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 171 | 0 | 15 |
| 2012 | 2 | — | 0 | 62 |
| 2013 | 1 | — | 1 (1) | 16 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 4 | 376 | 0 | 1 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 51 |
| 2024 | 0 | — | 0 | 133 |
| 2025 | 2 | — | 0 | 46 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The SCIS will be used to inflate to 25±2 cmH2O the cuff of a high-volume, low-pressure endotracheal tube that has been intubated by a trained medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112915: Spirtius Cuff Inflation Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112915
Report an extraction error
Are you the manufacturer?
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