# K954021: External Drainage System (Eds and Eds II)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Oct 24, 1995 after 85 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K061568: Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 (2006), 4 descendants of its own
- K162437: Codman EDS3 CSF External Drainage System (2016), 1 descendant of its own
- K121248: Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac (2013), 1 descendant of its own
- K983799: Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl (1999), 1 descendant of its own
- K201118: Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level (2020), 0 descendants of its own

## Recalls of this device
- Aug 4, 2006 · Not classified · Z-1533-06: Sterility of device is compromised due to package seal defects

Source page: https://510kreport.com/device/K954021
Methodology: https://510kreport.com/methodology