510(k) · Cleared
ClearedPylant Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kal-Med, LLC · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Feb 24, 2020 as substantially equivalent to K833327 (Respironics, Inc., 1983) after a 228-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Feb 24, 2020
- Review
- 228 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833327 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK833327 Respironics PR ValveRespironics, Inc. · 1983
- This deviceK191858 Pylant MonitorKal-Med, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833327 | Respironics PR Valve | Respironics, Inc. | 1983 | — |
| 0 (this device) | K191858 | Pylant Monitor | Kal-Med, LLC | 2020 | — |
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? (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 |
|---|---|---|---|
| * | K833327 | Respironics PR ValveSummary page 4…10(k) Name Company Number PYLANT Monitor PressureEasy Smiths K833327 Medical… | 1983 |
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.
- 2 other devices also cite its predicate K833327.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191858: Pylant Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191858
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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