510(k) · Cleared
ClearedFlextime
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, Inc. · ELW Material, Impression
Cleared on Apr 5, 2000 after a 41-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 5, 2000
- Review
- 41 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 5 citing it directly.
- This deviceK000629 FlextimeHeraeus Kulzer, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK113574 Flexitime Monophase Pro ScanHeraeus Kulzer, LLC · 2012
- Descendant · cites it directly · 0 of its ownK132869 SildentHrs Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK130647 Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set…Heraeus Kulzer, LLC · 2013
- Descendant · cites it directly · 0 of its ownK120914 Flexitime Fast & Scan Light FlowHeraeus Kulzer, LLC · 2012
- Descendant · cites it directly · 0 of its ownK091494 Flexitime FlowHeraeus Kulzer, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K113574Flexitime Monophase Pro ScanHeraeus Kulzer, LLC · 2012 · cites it directly1descendant
- K132869SildentHrs Co., Ltd. · 2014 · cites it directly0descendants
- K130647Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50MLHeraeus Kulzer, LLC · 2013 · cites it directly0descendants
- K120914Flexitime Fast & Scan Light FlowHeraeus Kulzer, LLC · 2012 · cites it directly0descendants
- K091494Flexitime FlowHeraeus Kulzer, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000629 | Flextime | Heraeus Kulzer, Inc. | 2000 | — |
| +1 | K113574 | Flexitime Monophase Pro Scan | Heraeus Kulzer, LLC | 2012 | — |
| +1 | K132869 | Sildent | Hrs Co., Ltd. | 2014 | — |
| +1 | K130647 | Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6… | Heraeus Kulzer, LLC | 2013 | — |
| +1 | K120914 | Flexitime Fast & Scan Light Flow | Heraeus Kulzer, LLC | 2012 | — |
| +1 | K091494 | Flexitime Flow | Heraeus Kulzer, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113574 (Heraeus Kulzer, LLC, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
https://510kreport.com/device/K000629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000629: Flextime.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000629
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026