510(k) · Cleared
ClearedTerumo Pressure Isolator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Dec 10, 2009 as substantially equivalent to K841959 (Sterile Design, Inc., 1984) after a 105-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Dec 10, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K841959 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK841959 Cardio Metric Custom Perfusion TubingSterile Design, Inc. · 1984 · Recalled
- This deviceK092644 Terumo Pressure IsolatorTerumo Cardiovascular Systems Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841959 | Cardio Metric Custom Perfusion Tubing | Sterile Design, Inc. | 1984 | 1 |
| 0 (this device) | K092644 | Terumo Pressure Isolator | Terumo Cardiovascular Systems Corp. | 2009 | — |
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 DRS? 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 DRS device
- #1 K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ…score 17.5 · 29 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 |
|---|---|---|---|
| * | K841959 | Cardio Metric Custom Perfusion TubingSummary page 2…the new Terumo device shall be demonstrated. The IBC Isolator is manufactured by International Biophysics Corporation and is legally marketed under 510(k) application K(841959. The 510(k) application was originally sponsored by Sterile Design, Incorporated in Oldsmar, Florida with an FDA decision date of… | 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 a recall.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DRS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRS
186in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRS
15in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DRS
187in 2025
MAUDE reports naming product code DRS, 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 | 1 | — | 0 | 397 |
| 2008 | 0 | — | 0 | 531 |
| 2009 | 2 | — | 0 | 344 |
| 2010 | 2 | — | 0 | 115 |
| 2011 | 3 | 135 | 0 | 63 |
| 2012 | 1 | — | 0 | 43 |
| 2013 | 1 | — | 0 | 39 |
| 2014 | 1 | — | 0 | 23 |
| 2015 | 1 | — | 0 | 60 |
| 2016 | 3 | 186 | 162 | 89 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 0 | — | 11 | 82 |
| 2019 | 0 | — | 0 | 84 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 93 |
| 2022 | 0 | — | 0 | 95 |
| 2023 | 1 | — | 15 | 147 |
| 2024 | 0 | — | 0 | 205 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 1 | — | 2 (2) | — |
What is it indicated for?
The pressure isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device may be used in procedures lasting up to 6 hours in duration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092644 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092644: Terumo Pressure Isolator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092644
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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