510(k) · Cleared
Recalled · Class II · 2016Celerity Sysyem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp (Medical Components, Inc.) · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jun 13, 2014 as substantially equivalent to K093775 (Romedex International Srl, 2010) after a 74-day review. Its family tree reaches back 9 generations to 2000. 1 of the 46 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled once.
- Decided
- Jun 13, 2014
- Review
- 74 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001901 (2000). 32 ancestors in all, the oldest K823434 (1982). 13 later devices descend from it, 2 citing it directly. 1 of the 46 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 2 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 1 generation backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- This deviceK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014
- Descendant · cites it directly · 8 of its ownK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 5 of its ownK152261 PICC Tip Positioning AidNostix, LLC · 2015
- Descendant · 3 generations on · 4 of its ownK160925 VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK200037 Piccolo Medical SmartPICC SystemPiccolo Medical, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK143238 C3 WaveMedcomp ( Medical Components) · 2015
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 4 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 3 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 2 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 1 generation backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- This deviceK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160925 VPS Rhythm Device with TipTracker Technology3 generations on · 2016
Most influential descendants
Showing 5 of 13 · See all- K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · cites it directly8descendants
- K152261PICC Tip Positioning AidNostix, LLC · 2015 · 2 generations on5descendants
- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 3 generations on4descendants
- K200037Piccolo Medical SmartPICC SystemPiccolo Medical, Inc. · 2021 · 2 generations on3descendants
- K143238C3 WaveMedcomp ( Medical Components) · 2015 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −4 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −3 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −2 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −1 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| 0 (this device) | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | — |
| +1 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 1 |
| +2 | K152261 | PICC Tip Positioning Aid | Nostix, LLC | 2015 | — |
| +3 | K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016 | Class I |
| +2 | K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | 2021 | — |
| +1 | K143238 | C3 Wave | Medcomp ( Medical Components) | 2015 | — |
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 | 3 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K093775 | Evguide Tip Location SystemSummary page 1…CFR: 21 CFRS8O.5970 Fax:215-256-1787 Class: 11 wiv.rnMedcvmpnet.com C. Predicate Devices K093775; Sapiens Tm Tip Location System… | 2010 |
What descends from it? (13)
See all 132 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 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 7 of the 32 ancestors have a recall of any class.
- Of its descendants, K142889 (AngioDynamics, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K093775.
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. 2014, 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 use as a supplemental aid in 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. Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy). Note: Limiting, but not contraindicated, situations for…
Read the full statement (112 words)
The Celerity System is indicated for use as a supplemental aid in 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. Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy).
Note: Limiting, but not contraindicated, situations for this technique, are patients where cardiac rhythm may change presentation of the P wave.
-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 to confirm catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140799: Celerity Sysyem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140799
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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