510(k) Report

510(k) · Cleared

Cleared

Xpedition ™ Powered Stair Chair (625700000000)

K222818510(k) TraditionalCleared Jan 24, 2023127-day reviewClass II21 CFR 890.5150

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

Stryker Medical · ILK Transport, Patient, Powered

Cleared on Jan 24, 2023 as substantially equivalent to K130864 (Aat Alber Antriebstechnik GmbH, 2014) after a 127-day review. Its family tree reaches back 3 generations to 1992.

Decided
Jan 24, 2023
Review
127 days
Class
Class II
Product code
ILK
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K920105 (1992). No later device cites it as a predicate yet.

  1. Root · 3 generations backK920105 ScalamobilAlber Technologies, Inc. · 1992
  2. 2 generations backK103122 C-Max, C-Max U1, C-Max U1 160KG, C-Max U2, C-Max U2 160KG, S-Max…Aat Alber Antriebstechnik GmbH · 2010
  3. 1 generation backK130864 C-Max+ (Plus)Aat Alber Antriebstechnik GmbH · 2014
  4. This deviceK222818 Xpedition ™ Powered Stair Chair (625700000000)Stryker Medical · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K920105ScalamobilAlber Technologies, Inc.1992—
−2K103122C-Max, C-Max U1, C-Max U1 160KG, C-Max U2, C-Max U2 160KG, S-Max, S-Max…Aat Alber Antriebstechnik GmbH2010—
−1K130864C-Max+ (Plus)Aat Alber Antriebstechnik GmbH2014—
0 (this device)K222818Xpedition ™ Powered Stair Chair (625700000000)Stryker Medical2023—
FIG. 1 — Lineage of K222818, 1992–2023Source: 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), 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 ILK? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K130864C-Max+ (Plus)
Summary page 4
…Classification Name: Transport, Patient, Powered (21 CFR 890.5150) Regulatory Class: II Product Code: ILK III. PREDICATE DEVICE C-Max +, K130864 This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Stryker Xpedition™…
Aat Alber Antriebstechnik GmbH2014—

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 31 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
  • None of the 3 ancestors has a recall.

How does its category compare?

All ILK devices

ILK Transport, Patient, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · ILK

1in 2024

2008: 12009: 12010: 22011: 12012: 32014: 12023: 12024: 1
2007high 3 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILK

150in 2012

2012: 150 days median
2007high 150 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ILK

1in 2012

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

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

Adverse event reports per year · ILK

32in 2025

2007: 12008: 42010: 12011: 12012: 42013: 42014: 22015: 22023: 52024: 182025: 32
2007high 32 (2025) · low 0 (2009)2025

MAUDE reports naming product code ILK, 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—01
20081—04
20091—00
20102—01
20111—01
2012315014
20130—04
20141—02
20150—02
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—05
20241—018
20250—032
20260—0—

What is it indicated for?

Xpedition transports a patient with a mobility-limiting medical condition or injury, who is physically able to maintain a seated position while restrained, up or down a set of stairs. Xpedition is intended for use in residential and commercial environments, including pre-hospital and hospital environments, emergency, and non-emergency applications. All operators, including healthcare professionals such as emergency medical service personnel and medical first responders, must be trained by a qualified trainer before product use.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K222818: Xpedition ™ Powered Stair Chair (625700000000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222818

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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