FDA product code · Orthopedic
Bit, Drill
FDA lists HTW as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 888.9 applies, such as a new intended use or a different fundamental technology. 11 FDA decisions since 1982. 30 recalls name this code, 0 of them Class I. The most-cited predicate is K942906, named by 1 later device.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of HTW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in HTW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 888.4540.