510(k) Report

510(k) · Cleared

Cleared

Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter System

K041771510(k) TraditionalCleared Sep 14, 200476-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, Inc. · LXC Monitor, Pressure, Intracompartmental

Cleared on Sep 14, 2004 after a 76-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided
Sep 14, 2004
Review
76 days
Class
Class U
Product code
LXC
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2014: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK041771 Twin Star Compartment Syndrome Pressure Monitoring and Fluid…Twin Star Medical, Inc. · 2004
  2. Descendant · cites it directly · 8 of its ownK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
  3. Descendant · 2 generations on · 7 of its ownK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
  4. Descendant · 3 generations on · 6 of its ownK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
  5. Descendant · 4 generations on · 5 of its ownK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
  6. 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

2009: 12014: 12020: 22021: 12022: 12023: 12025: 12026: 1
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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041771Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection…Twin Star Medical, Inc.2004—
+1K090961Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System…Twin Star Medical, Inc.2009—
+2K131966Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter…Twin Star Medical, Inc.2014—
+3K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2020—
+4K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2020—
+5K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201410
202020
202110
202210
202310
202510
202610
FIG. 1 — Lineage of K041771, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242997 MY01 Continuous Compartmental Pressure Monitorscore 14.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Stryker Intra-Compartment Pressure Monitor System
Named without a submission number
—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K090961Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)Twin Star Medical, Inc.20098

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?

  • Of its descendants, K090961 (Twin Star Medical, Inc., 2009) has gone furthest, with 8 descendants of its own.

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

2009: 12014: 12020: 22021: 12022: 12023: 12025: 12026 (partial year): 1
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

2012: 42013: 82014: 22015: 12016: 12021: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—04
20130—08
20141—02
20150—01
20160—01
20170—00
20180—00
20190—00
20202—00
20211—01
20221—00
20231—00
20240—00
20251—00
20261—0—

What is it indicated for?

The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is intended for the immediate or continuous measurement 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.

Indications for use as stated in the FDA summary.

More from Twin Star Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K131966Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter SystemTwin Star Medical, Inc. · 2014
  • K090961Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)Twin Star Medical, Inc. · 2009

Recent decisions in LXC

The LXC category page

  • K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026
  • K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025
  • K223509Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG · 2023
  • K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
  • K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 20211 recall

https://510kreport.com/device/K041771 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041771: Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041771

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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