510(k) · Cleared
Recalled · Class II · 2016Celerity PICC Tip Confirmation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jan 27, 2015 as substantially equivalent to K140799 (Medcomp (Medical Components, Inc.), 2014) and 1 other predicate after a 116-day review. Its family tree reaches back 10 generations to 2000. 1 of the 42 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 27, 2015
- Review
- 116 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K001901 (2000). 33 ancestors in all, the oldest K823434 (1982). 8 later devices descend from it, 3 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 2 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 1 generation backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- This deviceK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK152261 PICC Tip Positioning AidNostix, LLC · 2015
- Descendant · 2 generations on · 4 of its ownK160925 VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK200037 Piccolo Medical SmartPICC SystemPiccolo Medical, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK240486 PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252792 PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 5 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 4 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 3 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 2 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 1 generation backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- This deviceK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160925 VPS Rhythm Device with TipTracker Technology2 generations on · 2016
Most influential descendants
Showing 5 of 8 · See all- K152261PICC Tip Positioning AidNostix, LLC · 2015 · cites it directly5descendants
- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 2 generations on4descendants
- K200037Piccolo Medical SmartPICC SystemPiccolo Medical, Inc. · 2021 · cites it directly3descendants
- K240486PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024 · 2 generations on2descendants
- K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −5 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −4 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −3 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −2 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| −1 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| 0 (this device) | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | — |
| +1 | 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 | K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | 2021 | — |
| +2 | K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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.
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? (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 | Decided |
|---|---|---|---|
| * | K140799 | Celerity SysyemSummary page 4…stem Common Name: PICC placement accessory Classification Name: Percutaneous, implanted, long-term intravascular Catheter Product Code: LIS, 21CFR 880.5970 Class: I K140799 Celerity™ System K093775 Sapiens ™ Tip Location System Common Name: PICC placement accessory Classification Name: Percutaneous… | 2014 |
| * | K093775 | Evguide Tip Location SystemSummary page 4…cement accessory Classification Name: Percutaneous, implanted, long-term intravascular Catheter Product Code: LIS, 21CFR 880.5970 Class: I K140799 Celerity™ System K093775 Sapiens ™ Tip Location System Common Name: PICC placement accessory Classification Name: Percutaneous, implanted, long-term int… | 2010 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2016 | Class II | Z-1137-2017 | Employee error | The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG… |
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 on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 8 of the 33 ancestors have a recall of any class.
- Of its descendants, K152261 (Nostix, LLC, 2015) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K140799.
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. 2015, 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 Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients. Note: In general, devices that utilize ECG technique to observe P-Wave are…
Read the full statement (119 words)
The Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
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 PICC insertion. Use of an additional confirmation method is necessary o 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/K142889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K142889: Celerity PICC Tip Confirmation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K142889
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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