510(k) Report

510(k) · Cleared

Cleared

Dyna Glide 2600 Roll-in Ambulance Cot (95759)

K972528510(k) TraditionalCleared Jul 28, 199721-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

Dyna Corp. · FPO Stretcher, Wheeled

Cleared on Jul 28, 1997 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jul 28, 1997
Review
21 days
Class
Class II
Product code
FPO
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K972528Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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 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—

What is it indicated for?

The Dyna GLIDE 2600 Roll-in Ambulance Cot is a PROFESSIONAL USE ONLY patient handling device with designed features "allowing the Cot to be easily rolled in and out of an ambulance patient compartment. The primary purpose of the Dyna GLIDE 2600 is to ease the medical movement of a patient in an emergency medical situation by qualified and trained Emergency Medical Technicians (EMT)/Attendants.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K972528: Dyna Glide 2600 Roll-in Ambulance Cot (95759).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972528

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026