# K140799: Celerity Sysyem

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp (Medical Components, Inc.)
- Decided: Jun 13, 2014 after 74 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 32 ancestors in all.
13 later devices descend from it; 2 cite it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093775: Evguide Tip Location System, Romedex International Srl (2010) Summary page 1.

## Most influential descendants
- K142889: Celerity PICC Tip Confirmation System (2015), 8 descendants of its own
- K152261: PICC Tip Positioning Aid (2015), 5 descendants of its own
- K160925: VPS Rhythm Device with TipTracker Technology (2016), 4 descendants of its own
- K200037: Piccolo Medical SmartPICC System (2021), 3 descendants of its own
- K143238: C3 Wave (2015), 3 descendants of its own

## Recalls of this device
- Sep 7, 2016 · Class II · Z-1137-2017: 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 d

## Indications for use
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.

Source page: https://510kreport.com/device/K140799
Methodology: https://510kreport.com/methodology