510(k) · Cleared
ClearedRenovo Life Hard Carbon Coated Drill Bit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovo Life, LLC · HTW Bit, Drill
Cleared on Jan 15, 2016 after a 210-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 15, 2016
- Review
- 210 days
- Class
- Class I
- Product code
- HTW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Mahe Surgical Drill Bits Named without a submission number | |
| † | K990846 | Amorphous Diamond Coated Drill | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All HTW devicesHTW Bit, Drill: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HTW
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HTW
Too few HTW 510(k)s in any year since 2007 to give a median.
Recalls per year · HTW
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTW
1,507in 2025
MAUDE reports naming product code HTW, 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 | 0 | — | 0 | 146 |
| 2008 | 0 | — | 5 | 216 |
| 2009 | 0 | — | 1 | 256 |
| 2010 | 0 | — | 0 | 270 |
| 2011 | 0 | — | 2 | 225 |
| 2012 | 0 | — | 5 | 256 |
| 2013 | 0 | — | 1 | 519 |
| 2014 | 0 | — | 0 | 409 |
| 2015 | 0 | — | 0 | 400 |
| 2016 | 1 | — | 0 | 595 |
| 2017 | 0 | — | 1 | 1,129 |
| 2018 | 0 | — | 0 | 1,240 |
| 2019 | 0 | — | 2 | 1,212 |
| 2020 | 0 | — | 1 | 1,245 |
| 2021 | 0 | — | 4 | 1,569 |
| 2022 | 0 | — | 0 | 1,519 |
| 2023 | 0 | — | 0 | 1,772 |
| 2024 | 0 | — | 0 | 1,422 |
| 2025 | 0 | — | 0 | 1,507 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151661: Renovo Life Hard Carbon Coated Drill Bit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151661
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026