510(k) · Cleared
ClearedCompass CT, Compass CT Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirador Biomedical · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Apr 18, 2014 as substantially equivalent to K112203 (Mirador Biomedical, Inc., 2011) and 1 other predicate after a 143-day review. Its family tree reaches back 6 generations to 1983. 1 later device descends from it.
- Decided
- Apr 18, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K831506 (1983). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK831506 Disp. Transducer W/Monitoring Kit TransSorensen Research · 1983 · Recalled
- 5 generations backK052828 Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc. · 2006 · Recalled
- 4 generations backK061573 Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · Recalled
- 3 generations backK091408 Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009
- 2 generations backK101518 Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010
- 1 generation backK112203 Compass Global Pressure, Compass Thoracentesis, Paracentesis…Mirador Biomedical, Inc. · 2011
- This deviceK133624 Compass CT, Compass CT PortMirador Biomedical · 2014
- Descendant · cites it directly · 0 of its ownK161408 Compass Cast and MAPCenturion Medical Products Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K161408Compass Cast and MAPCenturion Medical Products Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K831506 | Disp. Transducer W/Monitoring Kit Trans | Sorensen Research | 1983 | 2 |
| −5 | K052828 | Disposable Transpac Iii Integrated Transducer (IT) | Hospira, Inc. | 2006 | 1 |
| −4 | K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | Hospira, Inc. | 2006 | 193 |
| −3 | K091408 | Disposable Pressure Transducer | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009 | — |
| −2 | K101518 | Compass Vascular Access; Compass Lumbar Puncture | Mirador Biomedical, Inc. | 2010 | — |
| −1 | K112203 | Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment… | Mirador Biomedical, Inc. | 2011 | — |
| 0 (this device) | K133624 | Compass CT, Compass CT Port | Mirador Biomedical | 2014 | — |
| +1 | K161408 | Compass Cast and MAP | Centurion Medical Products Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 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 17.4 · 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? (2)
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 |
|---|---|---|---|
| * | K112203 | Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure…Summary page 3…anical operation, tests completed on the predicate Compass Compartment Pressure and Compass Vascular Access Port and included previously in support of Mirador 5 l0(k)s KI112203 and K101518 have been used to verify design requirements for the subject Compass CT and CT Port devices. However, the subject Com… | 2011 |
| * | K101518 | Compass Vascular Access; Compass Lumbar PunctureSummary page 2…evices with respect to classification, design principles, and/or indications for use: * Compass Compartment Pressure - KI 12203 * Compass Vascular Access Port - K 101518 Device Testing: The subject Compass CT and CT Port are new Compass models in an existing Mirador product line of disposable pres… | 2010 |
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 |
|---|---|---|---|
| K161408 | Compass Cast and MAP | 2016 | 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?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K161408 (Centurion Medical Products Corporation, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112203.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Compass CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
The Compass CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133624: Compass CT, Compass CT Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133624
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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