510(k) · Cleared
ClearedPiccolo Medical SmartPICC System
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 Jan 22, 2021 as substantially equivalent to K142889 (AngioDynamics, Inc., 2015) after a 380-day review. Its family tree reaches back 11 generations to 2000. 3 later devices descend from it.
- Decided
- Jan 22, 2021
- Review
- 380 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001901 (2000). 34 ancestors in all, the oldest K823434 (1982). 3 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 2 generations backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 1 generation backK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- This deviceK200037 Piccolo Medical SmartPICC SystemPiccolo Medical, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK240486 PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK252792 PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243484 PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 6 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 5 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 4 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 3 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 2 generations backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 1 generation backK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- This deviceK200037 Piccolo Medical SmartPICC SystemPiccolo Medical, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −6 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −5 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −4 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −3 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| −2 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| −1 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 1 |
| 0 (this device) | K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | 2021 | — |
| +1 | K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024 | — |
| +2 | K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025 | — |
| +1 | K243484 | PM2+ System and SmartPICC Stylet | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 LJS? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142889 | Celerity PICC Tip Confirmation SystemSummary page 4…Product Code: LJS Review Panel: General Hospital III. PREDICATE DEVICE Angiodynamics Celerity PICC Tip Positioning Aid (K142889) Vasonova VPS System (K103255) – Reference Device… | 2015 |
| † | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | 2011 |
What descends from it? (3)
2 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 21 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 9 of the 34 ancestors have a recall of any class.
- Of its descendants, K240486 (Piccolo Medical, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K142889.
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. 2021, 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 Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen diameter of 0.021”. The SmartPICC system provides real-time catheter tip location information by using the patient’s cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip…
Read the full statement (178 words)
The Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen diameter of 0.021”. The SmartPICC system provides real-time catheter tip location information by using the patient’s cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system includes a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation.
Note: Use of the intravascular ECG (ivECG) technique to replace x-ray/fluoroscopy confirmation of tip placement is limited, but not contraindicated, for patients where alterations of cardiac rhythm change the presentation of the P-wave such as in atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and chronic obstructive pulmonary disease (COPD). In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional confirmation method (x-ray or fluoroscopy) is required to confirm catheter tip location.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200037 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200037: Piccolo Medical SmartPICC System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200037
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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