510(k) · Cleared

Cleared

Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor)

K060963510(k) TraditionalCleared Jun 6, 200660-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Twin Star Medical · LXC Monitor, Pressure, Intracompartmental

Cleared on Jun 6, 2006 as substantially equivalent to K844214 (Stryker Corp., 1985) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1985. 9 later devices descend from it.

Decided: Jun 6, 2006
Review: 60 days
Class: Class U
Product code: LXC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K844214 (1985). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
This deviceK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
Descendant · cites it directly · 8 of its ownK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
Descendant · 2 generations on · 7 of its ownK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
Descendant · 3 generations on · 6 of its ownK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
Descendant · 4 generations on · 5 of its ownK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
Descendant · 5 generations on · 4 of its ownK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009high 2 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all

K090961Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)Twin Star Medical, Inc. · 2009 · cites it directly8descendants
K131966Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter SystemTwin Star Medical, Inc. · 2014 · 2 generations on7descendants
K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020 · 3 generations on6descendants
K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020 · 4 generations on5descendants
K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K844214	Compartment Syndrome Pressure Monitor Sys	Stryker Corp.	1985	1
0 (this device)	K060963	Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS…	Twin Star Medical	2006	—
+1	K090961	Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System…	Twin Star Medical, Inc.	2009	—
+2	K131966	Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter…	Twin Star Medical, Inc.	2014	—
+3	K193321	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	2020	—
+4	K202635	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	2020	—
+5	K210525	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	2021	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2014	1	0
2020	2	0
2021	1	0
2022	1	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K060963, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LXC? 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 LXC device

#1 K242997 MY01 Continuous Compartmental Pressure Monitorscore 14.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K844214	Compartment Syndrome Pressure Monitor Sys Summary page 1 …nt Predicate Devices: Stryker Corporation Intracompartmental Syndrome Pressure Monitor System (K844214) Medela Corporation Median Vacuum Pump (K983552) Description of the…	Stryker Corp.	1985	1
*	K983552	Basic, Median, Dominant, and Vario Summary page 1 …ome Pressure Monitor System (K844214) Medela Corporation Median Vacuum Pump (K983552) Description of the Device The Twin Star Compartment Pressure Monitoring and Fluid Collection (CMS) Monitor displays and records…	Medela, Inc.	1999	—

Also cleared against K844214: 2 other devices →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090961	Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)	Twin Star Medical, Inc.	2009	8

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K090961 (Twin Star Medical, Inc., 2009) has gone furthest, with 8 descendants of its own.
2 other devices also cite its predicate K844214.

How does its category compare?

All LXC devices

LXC Monitor, Pressure, Intracompartmental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXC

1in 2025

2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXC

Too few LXC 510(k)s in any year since 2007 to give a median.

Recalls per year · LXC

No recall names LXC since 2007.

Adverse event reports per year · LXC

1in 2021

2007high 8 (2013) · low 0 (2007)2025

MAUDE reports naming product code LXC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	4
2013	0	—	8
2014	1	—	2
2015	0	—	1
2016	0	—	1
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	2	—	0
2021	1	—	1
2022	1	—	0
2023	1	—	0
2024	0	—	0
2025	1	—	0
2026	1	—	—

What is it indicated for?

The Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor) is intended for the measurement and monitoring of intracompartmental pressures and the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The CMS Monitor is intended to be used in conjunction with the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060963 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060963: Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060963

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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