510(k) Report

510(k) · Cleared

Cleared

Dale Gastrostomy Tube Holder

K961693510(k) TraditionalCleared Jul 30, 199690-day reviewClass II21 CFR 876.5980

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

Dale Medical Products, Inc. · PLI Gastrointestional Tube Holder

Cleared on Jul 30, 1996 after a 90-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, 1996
Review
90 days
Class
Class II
Product code
PLI
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 K961693Source: 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.

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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 PLI devices

PLI Gastrointestional Tube Holder: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · PLI

FDA has decided no PLI device since 2007.

Median 510(k) review, days · PLI

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

Recalls per year · PLI

No recall names PLI since 2007.

Adverse event reports per year · PLI

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2025

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

More from Dale Medical Products, Inc.

13 FDA decisions under this applicant name. See the company

  • K082241The Dale Ace Connector (Access Controller for Enteral), Model H84104751Dale Medical Products, Inc. · 2008
  • K994300Nasogastric Tube Holder, Model 160Dale Medical Products, Inc. · 2000
  • K964399Dale Endotracheal Tube Holder 270/280Dale Medical Products, Inc. · 1997
  • K951491Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsDale Medical Products, Inc. · 1995
  • K914245Dale (R) Nasal Dressing Holder (Product NO. 600)Dale Medical Products, Inc. · 1991

https://510kreport.com/device/K961693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961693: Dale Gastrostomy Tube Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961693

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