510(k) · Cleared
ClearedPM2™ System with ECGuide™ Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piccolo Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Nov 17, 2025 as substantially equivalent to K241910 (Navi Medical Technologies, 2025) and 2 other predicates after a 76-day review. Its family tree reaches back 14 generations to 2000. 1 of the 45 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 17, 2025
- Review
- 76 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K001901 (2000). 44 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet. 1 of the 45 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations between
- 3 generations backK152261 PICC Tip Positioning AidNostix, LLC · 2015
- 2 generations backK160925 VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
- 1 generation backK240486 PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024
- This deviceK252792 PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 13 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 12 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 11 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 10 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 9 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 8 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 7 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 6 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 5 generations backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 4 generations backK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- 3 generations backK152261 PICC Tip Positioning AidNostix, LLC · 2015
- 2 generations backK160925 VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
- 1 generation backK240486 PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024
- This deviceK252792 PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
Class I recalls in this family
- K160925 VPS Rhythm Device with TipTracker Technology2 generations back · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −13 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −12 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −11 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −10 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −9 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −8 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −7 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −6 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| −5 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| −4 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 1 |
| −3 | K152261 | PICC Tip Positioning Aid | Nostix, LLC | 2015 | — |
| −2 | K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016 | Class I |
| −1 | K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024 | — |
| 0 (this device) | K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 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 |
|---|---|---|---|
| * | K241910 | Neonav ECG Tip Location SystemSummary page 5…Primary 510(k) Number Predicate Device Name / Manufacturer Predicate K241910 Neonav ECG Tip Location System K240486 PM2™ System with ECGuide™ Connector… | 2025 |
| * | K240486 | PM2 System and ECGuide ConnectorSummary page 5…Predicate K241910 Neonav ECG Tip Location System K240486 PM2™ System with ECGuide™ Connector K180560 Sherlock 3CG+™ Tip Confirmation System (TCS) The predicate devi… | 2024 |
| * | K180560 | Sherlock 3CG+ T ip Confirmation SystemSummary page 5…Predicate K241910 Neonav ECG Tip Location System K240486 PM2™ System with ECGuide™ Connector K180560 Sherlock 3CG+™ Tip Confirmation System (TCS) The predicate devices have not been subject to a design related recall.… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 44 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K241910.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous access devices (CVADs) of at least 1Fr in size. It provides catheter tip location information by using the patient's cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of all central venous access devices. In adult patients and in adolescents (greater than…
Read the full statement (245 words)
The PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous access devices (CVADs) of at least 1Fr in size. It provides catheter tip location information by using the patient's cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of all central venous access devices.
In adult patients and in adolescents (greater than 12 through 21 years of age), The ECGuide™ can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), ECGuide™ can be used with PICCs and with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), ECGuide™ can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD’s indications and instructions for use.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including
-Atrial fibrillation
-Atrial flutter
-Severe tachycardia
-Pacemaker-driven rhythm
-Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252792 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252792: PM2™ System with ECGuide™ Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252792
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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