# K984053: Becker External Drainage and Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic PS Medical
- Decided: Feb 4, 1999 after 90 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 6 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902257 (1990). 2 ancestors in all.
13 later devices descend from it; 5 cite it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902257: Codman* External Drainage System II (Eds-II), Codman & Shurtleff, Inc. (1990) Summary page 1.
- K910938: Codman External Drainage System II (Eds II), Codman & Shurtleff, Inc. (1991). Our OCR of the scanned summary read K920938, FDA’s number for VJW2919 Pneumatic Compression Upgrade (Varian Canada, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Codman External Drainage System II”.

## Most influential descendants
- K171880: IRRAflow CNS System (2018), 4 descendants of its own
- K161605: Smart External Drain (SED) System (2016), 4 descendants of its own
- K192289: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (2019), 3 descendants of its own
- K171586: Smart External Drain (SED) System (2017), 3 descendants of its own
- K200807: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (2020), 2 descendants of its own

## Recalls of this device
- Jun 28, 2023 · Class II · Z-2412-2023: Product labeling contains incorrect expiration date
- Jun 9, 2014 · Class I · Z-1920-2014: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconne
- Jun 9, 2014 · Class I · Z-1923-2014: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconne
- Jun 9, 2014 · Class I · Z-1921-2014: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconne
- Jun 9, 2014 · Class I · Z-1922-2014: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconne
- Jun 9, 2014 · Class I · Z-1924-2014: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconne

## Indications for use
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative; monitor CSF chemistry, cytology and physiology; provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with severe head injury; subarachnoid hemorrhage graded lii, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.

Source page: https://510kreport.com/device/K984053
Methodology: https://510kreport.com/methodology