# K240319: DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

- Pathway: 510(k) (Traditional)
- Applicant: Pro Med Instruments GmbH
- Decided: Apr 24, 2024 after 82 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K944964 (1995). 49 ancestors in all.
No later device cites it as a predicate yet.
1 of 50 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191740: DORO LUCENT® iXI and iMRI Headrest System, Pro Med Instruments GmbH (2020) Summary page 6.

## Indications for use
The DORO LUCENT Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The DORO LUCENT Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.

Source page: https://510kreport.com/device/K240319
Methodology: https://510kreport.com/methodology