# K954611: Drager PT4000 Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Dec 1, 1995 after 58 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971198: Babytherm 8004 Babytherm 8010 (1997), 2 descendants of its own
- K993051: Versalet 7700 Care Center, Model # 7700 (2000), 1 descendant of its own
- K053399: Versalet 7700 Care Center (2006), 0 descendants of its own

## Recalls of this device
- Jul 2, 2012 · Class II · Z-1950-2012: A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse 

Source page: https://510kreport.com/device/K954611
Methodology: https://510kreport.com/methodology