# K000629: Flextime

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Apr 5, 2000 after 41 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 5 cite it directly.
0 of 6 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
- K113574: Flexitime Monophase Pro Scan (2012), 1 descendant of its own
- K132869: Sildent (2014), 0 descendants of its own
- K130647: Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50ML (2013), 0 descendants of its own
- K120914: Flexitime Fast & Scan Light Flow (2012), 0 descendants of its own
- K091494: Flexitime Flow (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K000629
Methodology: https://510kreport.com/methodology