510(k) · Cleared
ClearedHT-Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D.T. Davis Enterprises Ltd. T/A Hovertech Int'L · FNG Lift, Patient, Ac-Powered
Cleared on Oct 3, 2012 as substantially equivalent to K041503 (D.T. Davis Enterprises, Ltd., 2004) after a 156-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Oct 3, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- FNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926411 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 FNG? 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 |
|---|---|---|---|
| * | K041503 | Hoverjack Air Patient Lift DeviceSummary page 1…0, Product Code FNG) Legally Marketed Device: HoverTech International HoverJack Air.Patient Lift 510(k)#: K041503 Device Description: The HT-Wedge is an inflatable wedge with square headrest and two intake appendages, one for the head and one… | 2004 |
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.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FNG devicesFNG Lift, Patient, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FNG
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · FNG
Too few FNG 510(k)s in any year since 2007 to give a median.
Recalls per year · FNG
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FNG
5in 2025
MAUDE reports naming product code FNG, 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 | 74 |
| 2008 | 0 | — | 1 | 125 |
| 2009 | 0 | — | 14 | 178 |
| 2010 | 0 | — | 0 | 95 |
| 2011 | 0 | — | 1 | 125 |
| 2012 | 1 | — | 0 | 93 |
| 2013 | 0 | — | 0 | 157 |
| 2014 | 0 | — | 0 | 51 |
| 2015 | 0 | — | 0 | 31 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 5 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121287: HT-Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121287
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026