510(k) Report

510(k) · Cleared

Cleared

Stryker Powered Stretcher

K942948510(k) TraditionalCleared Jan 24, 1995215-day reviewClass II21 CFR 880.6910

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

Stryker Corp. · FPO Stretcher, Wheeled

Cleared on Jan 24, 1995 after a 215-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 25 later devices descend from it.

Decided
Jan 24, 1995
Review
215 days
Class
Class II
Product code
FPO
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2002: 1 descendant cleared2008: 1 descendant cleared2009: 2 descendants cleared2011: 4 descendants cleared2014: 2 descendants cleared2005: 1 descendant cleared1998: 1 descendant cleared2013: 1 descendant cleared2000: 1 descendant cleared2016: 1 descendant cleared2006: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2023: 2 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK942948 Stryker Powered StretcherStryker Corp. · 1995
  2. Descendant · cites it directly · 20 of its ownK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
  3. Descendant · 2 generations on · 11 of its ownK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
  4. Descendant · 3 generations on · 10 of its ownK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
  5. Descendant · 3 generations on · 9 of its ownK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
  6. Descendant · 4 generations on · 8 of its ownK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12000: 12002: 12005: 12006: 12008: 12009: 22011: 42013: 12014: 22016: 12017: 12019: 12021: 12023: 22025: 22026: 1
1997high 4 (2011) · low 0 (1999)2026

Most influential descendants

Showing 5 of 25 · See all
  • K022309Stryker Powered Wheeled StretcherStryker Corp. · 2002 · cites it directly20descendants
  • K090136Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · 2 generations on11descendants
  • K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection…Ortho Kinematics, Inc. · 2011 · 3 generations on10descendants
  • K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc. · 2013 · 3 generations on9descendants
  • K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc. · 2014 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942948Stryker Powered StretcherStryker Corp.1995—
+1K022309Stryker Powered Wheeled StretcherStryker Corp.20026
+2K090136Steris Cmax XLT Surgical TableSTERIS Corporation20094
+3K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data…Ortho Kinematics, Inc.2011—
+3K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc.2013—
+4K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc.20144

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200010
200210
200510
200610
200810
200920
201140
201310
201420
201610
201710
201910
202110
202320
202520
202610
FIG. 1 — Lineage of K942948, 1995–2026Source: 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.

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  • 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? (25)

See all 25

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022309Stryker Powered Wheeled StretcherStryker Corp.200220
K970074Stanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D)Hill-Rom, Inc.19973

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, K022309 (Stryker Corp., 2002) has gone furthest, with 20 descendants of its own.

How does its category compare?

All FPO devices

FPO Stretcher, Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPO

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPO

Too few FPO 510(k)s in any year since 2007 to give a median.

Recalls per year · FPO

1in 2025

2007: 62008: 32009: 122010: 12011: 62012: 12014: 12016: 12022: 22025: 12026 (partial year): 2
2007high 12 (2009) · low 0 (2013)2026

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

Adverse event reports per year · FPO

897in 2025

2007: 1172008: 3852009: 2,3372010: 4,0492011: 5,8912012: 6,3342013: 5,7432014: 1,6332015: 3812016: 2052017: 2302018: 5732019: 6632020: 6942021: 8742022: 6942023: 1,0282024: 9562025: 897
2007high 6,334 (2012) · low 117 (2007)2025

MAUDE reports naming product code FPO, 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—6117
20081—3385
20090—122,337
20100—14,049
20111—65,891
20120—16,334
20130—05,743
20140—11,633
20150—0381
20160—1205
20170—0230
20180—0573
20190—0663
20200—0694
20210—0874
20220—2694
20230—01,028
20240—0956
20250—1897
20260—2—
Cite this page

510(k) Report. “K942948: Stryker Powered Stretcher.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K942948

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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