510(k) · Cleared
ClearedCompass Vascular Access; Compass Lumbar Puncture
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 Oct 13, 2010 as substantially equivalent to K091408 (Shenzhen Ant Hi-Tech Industrial Co., Ltd., 2009) and 2 other predicates after a 133-day review. Its family tree reaches back 4 generations to 1983. 6 later devices descend from it.
- Decided
- Oct 13, 2010
- Review
- 133 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K831506 (1983). 7 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK831506 Disp. Transducer W/Monitoring Kit TransSorensen Research · 1983 · Recalled
- 3 generations backK052828 Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc. · 2006 · Recalled
- 2 generations backK061573 Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · Recalled
- 1 generation backK091408 Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009
- This deviceK101518 Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK112203 Compass Global Pressure, Compass Thoracentesis, Paracentesis…Mirador Biomedical, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK142245 EpiAccess SystemEpiep, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK133624 Compass CT, Compass CT PortMirador Biomedical · 2014
- Descendant · cites it directly · 0 of its ownK254074 TruPressProcerus Enterprises · 2026
- Descendant · 3 generations on · 0 of its ownK170831 EpiAccess SystemEpiep, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K112203Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure…Mirador Biomedical, Inc. · 2011 · cites it directly4descendants
- K142245EpiAccess SystemEpiep, Inc. · 2014 · 2 generations on1descendant
- K133624Compass CT, Compass CT PortMirador Biomedical · 2014 · cites it directly1descendant
- K254074TruPressProcerus Enterprises · 2026 · cites it directly0descendants
- K170831EpiAccess SystemEpiep, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831506 | Disp. Transducer W/Monitoring Kit Trans | Sorensen Research | 1983 | 2 |
| −3 | K052828 | Disposable Transpac Iii Integrated Transducer (IT) | Hospira, Inc. | 2006 | 1 |
| −2 | K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | Hospira, Inc. | 2006 | 193 |
| −1 | K091408 | Disposable Pressure Transducer | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009 | — |
| 0 (this device) | K101518 | Compass Vascular Access; Compass Lumbar Puncture | Mirador Biomedical, Inc. | 2010 | — |
| +1 | K112203 | Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment… | Mirador Biomedical, Inc. | 2011 | — |
| +2 | K142245 | EpiAccess System | Epiep, Inc. | 2014 | — |
| +1 | K133624 | Compass CT, Compass CT Port | Mirador Biomedical | 2014 | — |
| +1 | K254074 | TruPress | Procerus Enterprises | 2026 | — |
| +3 | K170831 | EpiAccess System | Epiep, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091408 | Disposable Pressure TransducerSummary page 2…o the following legally marketed devices with respect to classification, design principles and/or indications for use: * Shenzhen Disposable Pressure Transducer - K091408 * Vigileo APCO/Oximetry Monitor and DDPT - K043065 * Stryker Intra-Compartmental Pressure Monitor System - K844214 D… | 2009 |
| * | K043065 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models MIHM1 and MIHM1PSummary page 2…classification, design principles and/or indications for use: * Shenzhen Disposable Pressure Transducer - K091408 * Vigileo APCO/Oximetry Monitor and DDPT - K043065 * Stryker Intra-Compartmental Pressure Monitor System - K844214 Device Testingl: Performance testing of the Compass VA and… | 2005 |
| * | K844214 | Compartment Syndrome Pressure Monitor SysSummary page 2…Shenzhen Disposable Pressure Transducer - K091408 * Vigileo APCO/Oximetry Monitor and DDPT - K043065 * Stryker Intra-Compartmental Pressure Monitor System - K844214 Device Testingl: Performance testing of the Compass VA and Compass LP devices included in vitro (bench), biocompatibility, packa… | 1985 |
What descends from it? (6)
3 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 27 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K112203 (Mirador Biomedical, Inc., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Comnpass TM Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure.
The CompaSSTm Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101518: Compass Vascular Access; Compass Lumbar Puncture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101518
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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