# K843263: Arrow-Johans Ecg Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Sep 20, 1984 after 31 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 2 cite it directly.
6 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093775: Evguide Tip Location System (2010), 34 descendants of its own
- K140799: Celerity Sysyem (2014), 13 descendants of its own
- K103255: Vascular Positioning System TM (VPS TM System) Stylet (2011), 10 descendants of its own
- K142889: Celerity PICC Tip Confirmation System (2015), 8 descendants of its own
- K112744: Sapiens Tip Confirmation System (2011), 7 descendants of its own

## Recalls of this device
- Apr 11, 2018 · Class II · Z-2014-2018: Product sterility may be compromised due to unsealed packaging.

Source page: https://510kreport.com/device/K843263
Methodology: https://510kreport.com/methodology