510(k) · Cleared
ClearedCompass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist, Arterial Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirador Biomedical, Inc. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Dec 14, 2011 as substantially equivalent to K101518 (Mirador Biomedical, Inc., 2010) and 1 other predicate after a 135-day review. Its family tree reaches back 5 generations to 1983. 4 later devices descend from it.
- Decided
- Dec 14, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K831506 (1983). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK831506 Disp. Transducer W/Monitoring Kit TransSorensen Research · 1983 · Recalled
- 4 generations backK052828 Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc. · 2006 · Recalled
- 3 generations backK061573 Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · Recalled
- 2 generations backK091408 Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009
- 1 generation backK101518 Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010
- This deviceK112203 Compass Global Pressure, Compass Thoracentesis, Paracentesis…Mirador Biomedical, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK142245 EpiAccess SystemEpiep, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK133624 Compass CT, Compass CT PortMirador Biomedical · 2014
- Descendant · 2 generations on · 0 of its ownK170831 EpiAccess SystemEpiep, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK161408 Compass Cast and MAPCenturion Medical Products Corporation · 2016
Most influential descendants
Showing 4 of 4 · See all- K142245EpiAccess SystemEpiep, Inc. · 2014 · cites it directly1descendant
- K133624Compass CT, Compass CT PortMirador Biomedical · 2014 · cites it directly1descendant
- K170831EpiAccess SystemEpiep, Inc. · 2017 · 2 generations on0descendants
- K161408Compass Cast and MAPCenturion Medical Products Corporation · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K831506 | Disp. Transducer W/Monitoring Kit Trans | Sorensen Research | 1983 | 2 |
| −4 | K052828 | Disposable Transpac Iii Integrated Transducer (IT) | Hospira, Inc. | 2006 | 1 |
| −3 | K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | Hospira, Inc. | 2006 | 193 |
| −2 | K091408 | Disposable Pressure Transducer | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009 | — |
| −1 | K101518 | Compass Vascular Access; Compass Lumbar Puncture | Mirador Biomedical, Inc. | 2010 | — |
| 0 (this device) | K112203 | Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment… | Mirador Biomedical, Inc. | 2011 | — |
| +1 | K142245 | EpiAccess System | Epiep, Inc. | 2014 | — |
| +1 | K133624 | Compass CT, Compass CT Port | Mirador Biomedical | 2014 | — |
| +2 | K170831 | EpiAccess System | Epiep, Inc. | 2017 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101518 | Compass Vascular Access; Compass Lumbar PunctureSummary page 3…ate the exact physical elements (e.g. housing, electronics) contained in the predicate Mirador products (e.g. the Compass Vascular Access that was the subject of 5l1O(k) K10 1518 & K 103715), except for a modified LCD display. All packaging materials, methods and processes and the sterilization process are… | 2010 |
| * | K103715 | Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial PressureSummary page 2…ivalent to the following legally marketed devices with respect to classification, design principles and/or indications for use: " Compass Vascular Access- K10I5IR & K103715 * ReavilMED Blood Pressure Monitoring System - K]01189 Mirador Biomedical, Inc. 510(… | 2011 |
| Kept off the family tree | K101189 | FDA’s K101189 is Reavillmed Pressure Monitoring System and Picc Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 9 ancestors have a recall of any class.
- Of its descendants, K142245 (Epiep, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K101518.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 CompaSSTm GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The CompaSSTm Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The CompaSSTM Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The…
Read the full statement (111 words)
The CompaSSTm GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The CompaSSTm Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The CompaSSTM Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The CompaSSTM Compartment Pressure disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The CompaSSTM Epidural Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
The CompaSSTm Arterial Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112203: Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist, Arterial Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112203
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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