510(k) Report

510(k) · Cleared

Cleared

Stryker Eclipse Warming Stretcher

K912237510(k) TraditionalCleared Jul 30, 199170-day reviewClass I21 CFR 878.4820

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

Stryker Medical · DWI Saw, Electrically Powered

Cleared on Jul 30, 1991 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 30, 1991
Review
70 days
Class
Class I
Product code
DWI
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K912237Source: FDA 510(k) database · 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 DWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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?

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.

How does its category compare?

All DWI devices

DWI Saw, Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWI

FDA has decided no DWI device since 2007.

Median 510(k) review, days · DWI

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

Recalls per year · DWI

No recall names DWI since 2007.

Adverse event reports per year · DWI

1in 2025

2007: 12009: 12013: 12014: 22015: 32016: 32017: 22020: 12025: 1
2007high 3 (2015) · low 0 (2008)2025

MAUDE reports naming product code DWI, 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
20080—00
20090—01
20100—00
20110—00
20120—00
20130—01
20140—02
20150—03
20160—03
20170—02
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

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https://510kreport.com/device/K912237 · printed Nov 5, 2026

Cite this page

510(k) Report. “K912237: Stryker Eclipse Warming Stretcher.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K912237

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