510(k) Report

510(k) · Cleared

Cleared

Saf-Lift/Saf-Kary

K926411510(k) TraditionalCleared Mar 31, 1993100-day reviewClass II21 CFR 880.5500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arjo-Century, Inc. · FNG Lift, Patient, Ac-Powered

Cleared on Mar 31, 1993 after a 100-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 31, 1993
Review
100 days
Class
Class II
Product code
FNG
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK926411 Saf-Lift/Saf-KaryArjo-Century, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK041503 Hoverjack Air Patient Lift DeviceD.T. Davis Enterprises, Ltd. · 2004
  3. Descendant · 2 generations on · 0 of its ownK121287 HT-WedgeD.T. Davis Enterprises Ltd. T/A Hovertech Int'L · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K041503Hoverjack Air Patient Lift DeviceD.T. Davis Enterprises, Ltd. · 2004 · cites it directly1descendant
  • K121287HT-WedgeD.T. Davis Enterprises Ltd. T/A Hovertech Int'L · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926411Saf-Lift/Saf-KaryArjo-Century, Inc.1993—
+1K041503Hoverjack Air Patient Lift DeviceD.T. Davis Enterprises, Ltd.2004—
+2K121287HT-WedgeD.T. Davis Enterprises Ltd. T/A Hovertech Int'L2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201210
FIG. 1 — Lineage of K926411, 1993–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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
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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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041503Hoverjack Air Patient Lift DeviceD.T. Davis Enterprises, Ltd.20041

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, K041503 (D.T. Davis Enterprises, Ltd., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FNG devices

FNG Lift, Patient, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FNG

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

2008: 12009: 142011: 12022: 1
2007high 14 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FNG

5in 2025

2007: 742008: 1252009: 1782010: 952011: 1252012: 932013: 1572014: 512015: 312016: 52017: 82018: 62019: 42020: 52021: 42022: 52023: 162024: 42025: 5
2007high 178 (2009) · low 4 (2019)2025

MAUDE reports naming product code FNG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—074
20080—1125
20090—14178
20100—095
20110—1125
20121—093
20130—0157
20140—051
20150—031
20160—05
20170—08
20180—06
20190—04
20200—05
20210—04
20220—15
20230—016
20240—04
20250—05
20260—0—
Cite this page

510(k) Report. “K926411: Saf-Lift/Saf-Kary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926411

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026