510(k) Report

510(k) · Cleared

Cleared

Tube-Title

K833361510(k) TraditionalCleared Nov 3, 198337-day reviewClass I21 CFR 868.5280

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

Sontek Industries, Inc. · JAY Support, Breathing Tube

Cleared on Nov 3, 1983 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 3, 1983
Review
37 days
Class
Class I
Product code
JAY
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K833361Source: 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 JAY? 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 has not posted a summary or statement for it, 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 JAY devices

JAY Support, Breathing Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAY

FDA has decided no JAY device since 2007.

Median 510(k) review, days · JAY

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

Recalls per year · JAY

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JAY

8in 2025

2007: 12011: 12012: 202013: 52014: 32017: 22018: 12019: 262020: 252021: 172022: 112023: 112024: 52025: 8
2007high 26 (2019) · low 0 (2008)2025

MAUDE reports naming product code JAY, 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—00
20100—00
20110—01
20120—020
20130—05
20140—03
20150—00
20160—00
20170—02
20180—01
20190—026
20200—025
20210—017
20220—111
20230—011
20240—05
20250—08
20260—0—

More from Sontek Industries, Inc.

7 FDA decisions under this applicant name. See the company

  • K833373Bodia Bronch-Saf Double SwivelSontek Industries, Inc. · 1983
  • K833372Bodia Trach-Saf Double SwivelSontek Industries, Inc. · 1983
  • K833374Bite-BlockSontek Industries, Inc. · 1983
  • K813324Bodai Swivel YSontek Industries, Inc. · 1981
  • K812720Bodai Patient CommunicatorSontek Industries, Inc. · 1981

Recent decisions in JAY

The JAY category page

  • K944988Custom Medical Suspension StrapCustom Medical Specialties, Inc. · 1995
  • K873491Block, Bite, IntubationB&B Medical Technologies, Inc. · 1987
  • K860583Dale Head Band Anesthesia Circuit Tube Holder 1315Dale Medical Products, Inc. · 1986
  • K850924Jee Frame (Ventilator Circuit Support)Vulcan Laboratories, Inc. · 1985
  • K850309Comfit Plus Endotracheal Tube Holder & Bite BlockAckrad Laboratories · 1985

https://510kreport.com/device/K833361 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833361: Tube-Title.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833361

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