Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LXC · Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

90 daysmedian FDA review time
224 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2026-01-162100
K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2025-03-131680
K223509Compremium Compartment Compressibility Monitoring System (CPCompremium AG2023-04-141430
K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2022-05-24530
K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2021-04-22580
K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2020-12-10900
K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc.2020-07-302410
K131966TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID CTwin Star Medical, Inc.2014-02-072240
K090961TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION Twin Star Medical, Inc.2009-06-12670
K060963TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTITwin Star Medical2006-06-06600
K041771TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUIDTwin Star Medical, Inc.2004-09-14760
K031555SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEMSynthes (Usa)2003-07-08500
K881858ACE ICPM SIDE PORTED NEEDLEBuckman Co., Inc.1988-05-27240
K873684ACE INTRA COMPARTMENTAL PRESSURE MONITORAce Medical Co.1988-01-201280
K844214COMPARTMENT SYNDROME PRESSURE MONITOR SYSStryker Corp.1985-04-041551

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda