510(k) Report

510(k) · Cleared

Cleared

Dale Tracheostomy Tube Holder with Trach Mask Attachment Tabs

K951491510(k) TraditionalCleared Apr 24, 199524-day reviewClass I21 CFR 868.5770

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. · CBH Device, Fixation, Tracheal Tube

Cleared on Apr 24, 1995 after a 24-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 24, 1995
Review
24 days
Class
Class I
Product code
CBH
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 K951491Source: 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 CBH? 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?

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 CBH devices

CBH Device, Fixation, Tracheal Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBH

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBH

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

Recalls per year · CBH

4in 2024

2007: 22024: 4
2007high 4 (2024) · low 0 (2008)2026

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

Adverse event reports per year · CBH

62in 2025

2007: 222008: 452009: 232010: 142011: 352012: 242013: 402014: 402015: 172016: 262017: 322018: 322019: 302020: 672021: 272022: 472023: 222024: 202025: 62
2007high 67 (2020) · low 14 (2010)2025

MAUDE reports naming product code CBH, 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—222
20080—045
20090—023
20100—014
20110—035
20120—024
20130—040
20141—040
20150—017
20160—026
20170—032
20180—032
20190—030
20200—067
20210—027
20220—047
20230—022
20240—420
20250—062
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
  • K961693Dale Gastrostomy Tube HolderDale Medical Products, Inc. · 1996
  • K914245Dale (R) Nasal Dressing Holder (Product NO. 600)Dale Medical Products, Inc. · 1991

Recent decisions in CBH

The CBH category page

  • K140097Amt Endotracheal Tube Bridle Retention SystemApplied Medical Technology, Inc. · 2014
  • K964399Dale Endotracheal Tube Holder 270/280Dale Medical Products, Inc. · 1997
  • K942529Hci Tube StabilizerHealth Care Contracts, Inc. · 1995
  • K950930Trache-TiteThe Varner Group, Inc. · 1995
  • K950318Flex BlueKing Systems Corp. · 1995

https://510kreport.com/device/K951491 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951491: Dale Tracheostomy Tube Holder with Trach Mask Attachment Tabs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951491

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